Kombinationskemoterapi med eller uden Ganitumab til behandling af patienter med nyligt diagnosticeret metastatisk Ewing-sarkom
Randomiseret fase 3-forsøg, der evaluerer tilføjelsen af det monoklonale IGF-1R-antistof Ganitumab (AMG 479, NSC# 750008) til multiagent kemoterapi til patienter med nyligt diagnosticeret metastatisk Ewing-sarkom
This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Medicin: Cyclophosphamide
- Medicin: Doxorubicin Hydrochloride
- Medicin: Doxorubicin
- Medicin: Vincristine
- Medicin: Vincristine Sulfate
- Medicin: Etoposide
- Medicin: Etoposide Phosphate
- Stråling: External Beam Radiation Therapy
- Medicin: Ifosfamide
- Stråling: Stereotactic Radiosurgery
- Procedure: Therapeutic Surgical Procedure
- Biologisk: Ganitumab
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine if event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab (AMG 479).
SECONDARY OBJECTIVES:
I. To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma.
II. To compare overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.
EXPLORATORY OBJECTIVES:
I. To compare bone marrow response rates in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.
II. To describe the toxicity of 6 months of ganitumab monotherapy as maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.
III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg.
IV. To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma.
V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
VI. To determine if EFS, overall survival, and bone marrow response rates differ based on protein, deoxyribose nucleic acid (DNA), and ribonucleic acid (RNA) marker in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma.
VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab.
IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET) to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic resonance imaging (MRI).
X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.
XI. To collect data on institutional testing for Ewing sarcoma breakpoint region 1 (EWSR1) translocation status in patients enrolling on study.
XII. To explore the capacity of plasma cell-free DNA analysis to detect tumor-specific genetic changes at initial diagnosis and after initiation of protocol therapy.
XIII. To collect a population of bone marrow metastatic tumor cells by flow cytometry for genomic profiling.
OUTLINE: Patients are randomized to 1 of 2 treatment regimens. (As of 3/20/2019, the study is closed to accrual and patients in Regimen B no longer receive ganitumab.)
REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and ifosfamide and etoposide phosphate [IE]):
INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1, doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2, and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9, and ifosfamide IV over 1 hour on days 1 to 5 and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.
LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7, cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13, ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15, and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.
METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or external beam radiation therapy (EBRT).
REGIMEN B (VDC/IE + ganitumab):
INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.
LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.
METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.
MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.
After completion of study treatment, patients are followed for 10 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Québec, Canada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Canada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, Forenede Stater, 36604
- USA Health Strada Patient Care Center
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, Forenede Stater, 85202
- Banner Children's at Desert
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, Forenede Stater, 85719
- Banner University Medical Center - Tucson
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Yuma, Arizona, Forenede Stater, 85364
- Onvida Health Yuma Medical Center
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Arkansas
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Hot Springs, Arkansas, Forenede Stater, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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Little Rock, Arkansas, Forenede Stater, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, Forenede Stater, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital Los Angeles
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Madera, California, Forenede Stater, 93636
- Valley Children's Hospital
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Oakland, California, Forenede Stater, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente-Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, Forenede Stater, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Forenede Stater, 92123
- Rady Children's Hospital - San Diego
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San Francisco, California, Forenede Stater, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, Forenede Stater, 94143
- UCSF Medical Center-Parnassus
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Torrance, California, Forenede Stater, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Denver, Colorado, Forenede Stater, 80210
- AdventHealth Porter
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Durango, Colorado, Forenede Stater, 81301
- Mercy Medical Center
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Durango, Colorado, Forenede Stater, 81301
- CommonSpirit Cancer Center Mercy
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Golden, Colorado, Forenede Stater, 80401
- Mountain Blue Cancer Care Center
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Lakewood, Colorado, Forenede Stater, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Forenede Stater, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Forenede Stater, 80122
- AdventHealth Littleton
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Longmont, Colorado, Forenede Stater, 80501
- Longmont United Hospital
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Longmont, Colorado, Forenede Stater, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Forenede Stater, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Forenede Stater, 80138
- AdventHealth Parker
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Pueblo, Colorado, Forenede Stater, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Forenede Stater, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, Forenede Stater, 80260
- Rocky Mountain Cancer Centers-Thornton
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Myers, Florida, Forenede Stater, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, Forenede Stater, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, Forenede Stater, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Forenede Stater, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, Forenede Stater, 32827
- Nemours Children's Hospital
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Orlando, Florida, Forenede Stater, 32803
- AdventHealth Orlando
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Orlando, Florida, Forenede Stater, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, Forenede Stater, 32504
- Nemours Children's Clinic - Pensacola
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St. Petersburg, Florida, Forenede Stater, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Forenede Stater, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, Forenede Stater, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Augusta, Georgia, Forenede Stater, 30912
- Augusta University Medical Center
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Savannah, Georgia, Forenede Stater, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Forenede Stater, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Lurie Children's Hospital-Chicago
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Danville, Illinois, Forenede Stater, 61832
- Carle at The Riverfront
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Effingham, Illinois, Forenede Stater, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, Forenede Stater, 62864
- SSM Health Good Samaritan
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, Forenede Stater, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Saint John's Hospital
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
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Urbana, Illinois, Forenede Stater, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Forenede Stater, 60560
- Rush-Copley Healthcare Center
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Indiana
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Evansville, Indiana, Forenede Stater, 47713
- Deaconess Clinic Downtown
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Indianapolis, Indiana, Forenede Stater, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, Forenede Stater, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Michigan City, Indiana, Forenede Stater, 46360
- Franciscan Saint Anthony Health-Michigan City
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Michigan City, Indiana, Forenede Stater, 46360
- Woodland Cancer Care Center
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Newburgh, Indiana, Forenede Stater, 47630
- Chancellor Center for Oncology
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Iowa
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Clive, Iowa, Forenede Stater, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Forenede Stater, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Forenede Stater, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50309
- Blank Children's Hospital
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Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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West Des Moines, Iowa, Forenede Stater, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
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Corbin, Kentucky, Forenede Stater, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky/Markey Cancer Center
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Lexington, Kentucky, Forenede Stater, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Forenede Stater, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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London, Kentucky, Forenede Stater, 40741
- CommonSpirit Saint Joseph Hospital London
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Louisville, Kentucky, Forenede Stater, 40202
- Jewish Hospital
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Louisville, Kentucky, Forenede Stater, 40202
- Norton Children's Hospital
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Louisville, Kentucky, Forenede Stater, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Forenede Stater, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Forenede Stater, 40165
- Jewish Hospital Medical Center South
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Forenede Stater, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Forenede Stater, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Forenede Stater, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, Forenede Stater, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Forenede Stater, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- C S Mott Children's Hospital
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Rogel Cancer Center
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Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48236
- Henry Ford Health Saint John Hospital
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49048
- Beacon Kalamazoo
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Muskegon, Michigan, Forenede Stater, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Forenede Stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Port Huron, Michigan, Forenede Stater, 48060
- Lake Huron Medical Center
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Port Huron, Michigan, Forenede Stater, 48060
- Huron Medical Center PC
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Reed City, Michigan, Forenede Stater, 49677
- Corewell Health Reed City Hospital
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Royal Oak, Michigan, Forenede Stater, 48073
- Corewell Health Children's
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Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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Missouri
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Bolivar, Missouri, Forenede Stater, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Forenede Stater, 65616
- Cox Cancer Center Branson
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Columbia, Missouri, Forenede Stater, 65212
- University of Missouri Children's Hospital
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Joplin, Missouri, Forenede Stater, 64804
- Freeman Health System
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Joplin, Missouri, Forenede Stater, 64804
- Mercy Hospital Joplin
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospitals and Clinics
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Rolla, Missouri, Forenede Stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Forenede Stater, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Forenede Stater, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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St Louis, Missouri, Forenede Stater, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Forenede Stater, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68123
- Nebraska Medicine-Bellevue
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Grand Island, Nebraska, Forenede Stater, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Forenede Stater, 68847
- CHI Health Good Samaritan
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Kearney, Nebraska, Forenede Stater, 68845
- Fred and Pamela Buffett Cancer Center - Kearney
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Lincoln, Nebraska, Forenede Stater, 68510
- Saint Elizabeth Regional Medical Center
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Omaha, Nebraska, Forenede Stater, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Forenede Stater, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Forenede Stater, 68118
- Nebraska Medicine-Village Pointe
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Omaha, Nebraska, Forenede Stater, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Forenede Stater, 68130
- Alegent Health Lakeside Hospital
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Omaha, Nebraska, Forenede Stater, 68114
- Children's Hospital and Medical Center of Omaha
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Omaha, Nebraska, Forenede Stater, 68122
- Hematology and Oncology Consultants PC
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Papillion, Nebraska, Forenede Stater, 68046
- Midlands Community Hospital
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Nevada
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Carson City, Nevada, Forenede Stater, 89703
- Carson Tahoe Regional Medical Center
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Henderson, Nevada, Forenede Stater, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
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Las Vegas, Nevada, Forenede Stater, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, Forenede Stater, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, Forenede Stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- Ann M Wierman MD LTD
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Pahrump, Nevada, Forenede Stater, 89048
- Hope Cancer Care of Nevada-Pahrump
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
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Reno, Nevada, Forenede Stater, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, Forenede Stater, 89509
- Radiation Oncology Associates
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, Forenede Stater, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Forenede Stater, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- Saint Joseph's Regional Medical Center
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New York
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Albany, New York, Forenede Stater, 12208
- Albany Medical Center
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
Glens Falls, New York, Forenede Stater, 12801
- Glens Falls Hospital
-
Mineola, New York, Forenede Stater, 11501
- NYU Langone Hospital - Long Island
-
New Hyde Park, New York, Forenede Stater, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
New York, New York, Forenede Stater, 10029
- Mount Sinai Hospital
-
New York, New York, Forenede Stater, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Forenede Stater, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester
-
Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Forenede Stater, 10467
- Children's Hospital at Montefiore
-
The Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Weiler Hospital
-
Valhalla, New York, Forenede Stater, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Forenede Stater, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Forenede Stater, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Forenede Stater, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Forenede Stater, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, Forenede Stater, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, Forenede Stater, 45404
- Dayton Children's Hospital
-
Toledo, Ohio, Forenede Stater, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Children's Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19134
- Saint Christopher's Hospital for Children
-
Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel University School of Medicine
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
Columbia, South Carolina, Forenede Stater, 29203
- Prisma Health Richland Hospital
-
Greenville, South Carolina, Forenede Stater, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Forenede Stater, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Forenede Stater, 29605
- BI-LO Charities Children's Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37403
- T C Thompson Children's Hospital
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Memorial Hospital
-
Hixson, Tennessee, Forenede Stater, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Knoxville, Tennessee, Forenede Stater, 37916
- East Tennessee Childrens Hospital
-
Memphis, Tennessee, Forenede Stater, 38105
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37203
- The Children's Hospital at TriStar Centennial
-
Ooltewah, Tennessee, Forenede Stater, 37363
- Memorial GYN Plus
-
-
Texas
-
Austin, Texas, Forenede Stater, 78723
- Dell Children's Medical Center of Central Texas
-
Bryan, Texas, Forenede Stater, 77802
- Saint Joseph Regional Cancer Center
-
Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, Forenede Stater, 79905
- El Paso Children's Hospital
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center
-
Houston, Texas, Forenede Stater, 77030
- UT MD Anderson Cancer Center
-
Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, Forenede Stater, 79415
- UMC Cancer Center / UMC Health System
-
Lubbock, Texas, Forenede Stater, 79430
- Texas Tech University Health Sciences Center-Lubbock
-
San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forenede Stater, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, Forenede Stater, 78229
- Methodist Children's Hospital of South Texas
-
Temple, Texas, Forenede Stater, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84113
- Primary Children's Hospital
-
-
Vermont
-
Berlin Corners, Vermont, Forenede Stater, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Forenede Stater, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, Forenede Stater, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Comprehensive Cancer Center
-
Roanoke, Virginia, Forenede Stater, 24014
- Carilion Children's
-
-
Washington
-
Burien, Washington, Forenede Stater, 98166
- Saint Anne Hospital
-
Enumclaw, Washington, Forenede Stater, 98022
- Saint Elizabeth Hospital
-
Federal Way, Washington, Forenede Stater, 98003
- Saint Francis Hospital
-
Lakewood, Washington, Forenede Stater, 98499
- Saint Clare Hospital
-
Poulsbo, Washington, Forenede Stater, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, Forenede Stater, 98105
- Seattle Children's Hospital
-
Silverdale, Washington, Forenede Stater, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Spokane, Washington, Forenede Stater, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Tacoma, Washington, Forenede Stater, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Forenede Stater, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Forenede Stater, 98431
- Madigan Army Medical Center
-
Tacoma, Washington, Forenede Stater, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Marinette, Wisconsin, Forenede Stater, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Children's Hospital of Wisconsin
-
-
-
-
-
San Juan, Puerto Rico, 00926
- University Pediatric Hospital
-
San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site
-
For the purpose of this study metastatic disease is defined as one or more of the following:
-
Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor; skip lesions in the same bone as the primary tumor do not constitute metastatic disease; skip lesions in an adjacent bone are considered bone metastases; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed
-
Contralateral pleural effusion and/or contralateral pleural nodules
-
Distant lymph node involvement
-
Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
- Solitary nodule >= 0.5 cm or multiple nodules of >= 0.3 cm unless lesion is biopsied and negative for tumor
- Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor
-
Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on hematoxylin and eosin (H&E) stains; in the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study
- This study requires bilateral bone marrow biopsies at study entry; the suggested approach for patients with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy)
-
Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or computed tomography (CT) (whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole body technetium bone scans may be performed at the discretion of the investigator and are not required; for patients without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry
-
-
Patients must have adequate tumor tissue to meet the minimum requirement for submission
-
Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required
-
Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):
- Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females
- Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and females
- Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females
- Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females
- Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females
- Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females
- Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for females
- Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for females
-
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment), and
-
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)
-
Shortening fraction of >= 27% or
-
Ejection fraction of >= 50%
-
Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
-
All patients and/or their parents or legal guardians must sign a written informed consent
-
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with regional node involvement as their only site of disease beyond the primary tumor will not be eligible
- Patients whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord) are not eligible
- Patients who have received prior chemotherapy or radiation therapy are not eligible
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy
- Patients with known pre-existing diabetes mellitus will be excluded from study
- Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Regimen A (VDC/IE)
See Design Details. |
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Undergo EBRT
Andre navne:
Given IV
Andre navne:
Undergo SBRT
Andre navne:
Undergo surgery |
|
Eksperimentel: Regimen B (VDC/IE + ganitumab)
INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. |
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Undergo EBRT
Andre navne:
Given IV
Andre navne:
Undergo SBRT
Andre navne:
Undergo surgery Given IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-free Survival
Tidsramme: 5 years after enrollment
|
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. |
5 years after enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: 5 years after enrollment
|
Time from study enrollment to death or last patient contact. |
5 years after enrollment
|
|
Frequency of Toxicity-events
Tidsramme: Up to 202 days
|
The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. |
Up to 202 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
Tidsramme: Up to 10 years
|
In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median. |
Up to 10 years
|
|
Tumor Cell Surface IGF-1R Expression
Tidsramme: Up to 307 days
|
Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively. |
Up to 307 days
|
|
Germline Polymorphisms in EGFR
Tidsramme: Up to 10 years
|
EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab. |
Up to 10 years
|
|
EWS Translocation
Tidsramme: Up to 10 years
|
The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated. |
Up to 10 years
|
|
Circulating Tumor DNA (ctDNA) Testing
Tidsramme: Up to 202 days
|
Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods. |
Up to 202 days
|
|
Serial Genomic Profiling
Tidsramme: Up to 307 days
|
Will be identified by flow cytometry. Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented. |
Up to 307 days
|
|
Occurrence of Sinusoidal Obstructive Disease (SOS) Associated With the Addition of Ganitumab to VDC/IE
Tidsramme: Up to 202 days
|
The number of induction and maintenance cycles received by patients randomized to the experimental therapy where SOS is observed. Only patients who receive all reporting period therapy or experience SOS will contribute to this outcome measure. |
Up to 202 days
|
|
Frequency of Resolution of Bone Marrow Metastases
Tidsramme: Up to 84 days
|
The number of patients who are enrolled with bone marrow metastases whose bone marrow disease is not detected after evaluation at the time of of first local control measure or the end of the Induction reporting period, whichever comes first. Only eligible patients who receive at least one dose of randomized treatment assignment will be considered for this measure. |
Up to 84 days
|
|
Frequency of Toxicity Events During Ganitumab Maintenance
Tidsramme: Up to 307 days
|
The number of induction or consolidation reporting periods in which a CTC version 4 codeable non-hematological adverse event, grade 3 left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. |
Up to 307 days
|
|
Trough Levels of Serum Ganitumab
Tidsramme: Up to 15 days
|
Trough levels of serum ganitumab prior to the second dose of ganitumab during induction obtained will be categorized as less than 10 micrograms per milliliter or greater than or equal to 10 micrograms per milliliter. This analysis will be conducted for the first 10 eligible patients who receive ganitumab. |
Up to 15 days
|
|
Proportion of Patients Who Successfully Receive Planned Stereotactic Body Radiotherapy (SBRT)
Tidsramme: 202 days
|
A patient who has SBRT planned for at least one metastatic site and receives successful SBRT treatment to at least 85% of metastatic sites in the treatment plan. Successful treatment is determined by IROC review criteria. Only eligible patients start the metastatic site radiation reporting period will be considered for this outcome measure. |
202 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Steven G DuBois, Children's Oncology Group
Publikationer og nyttige links
Generelle publikationer
- DuBois SG, Krailo MD, Glade-Bender J, Buxton A, Laack N, Randall RL, Chen HX, Seibel NL, Boron M, Terezakis S, Hill-Kayser C, Hayes A, Reid JM, Teot L, Rakheja D, Womer R, Arndt C, Lessnick SL, Crompton BD, Kolb EA, Daldrup-Link H, Eutsler E, Reed DR, Janeway KA, Gorlick RG. Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2023 Apr 10;41(11):2098-2107. doi: 10.1200/JCO.22.01815. Epub 2023 Jan 20.
- von Kruchten R, DelRocco NJ, Adams LC, Singh SB, Varniab ZS, Bender JG, Krailo MD, DuBois S, Daldrup-Link HE. Role of diffusion-weighted MRI in assessing Ewing sarcoma treatment response: Findings from a COG phase III trial. Magn Reson Imaging. 2026 Oct;132:110706. doi: 10.1016/j.mri.2026.110706. Epub 2026 May 27.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Sarkom
- Neoplasmer, bindevæv og blødt væv
- Osteosarkom
- Neoplasmer, Knoglevæv
- Neoplasmer, bindevæv
- Sarkom, Ewing
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Undersøgelsesteknikker
- Terapeutik
- Kirurgiske procedurer, operative
- Kulbrinter
- Kulbrinter, cyklisk
- Kulhydrater
- Fysiske fænomener
- Alkaloider
- Podophyllotoxin
- Tetrahydronaphthalenes
- Naphthalenes
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Glukosider
- Glycosider
- Indoler
- Organisationer
- Sundhedsøkonomi og organisationer
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Kulbrinter, halogeneret
- Phosphoramider
- Organophosphorforbindelser
- Vinca alkaloider
- Secologanin tryptamin alkaloider
- Indole alkaloider
- Indolizidiner
- Indolizines
- Anthracycliner
- Naphthacenes
- Aminoglycosider
- Strålebehandling
- Stereotaksiske teknikker
- Neurokirurgiske procedurer
- Daunorubicin
- Oxaziner
- Cyclofosfamid
- Etoposid
- Doxorubicin
- Vincristine
- Ifosfamid
- Stråling
- Kongresser som emne
- Radiokirurgi
- Etoposidphosphat
- Ganitumab
Andre undersøgelses-id-numre
- NCI-2014-02380
- U10CA180886 (U.S. NIH-bevilling/kontrakt)
- U10CA098543 (U.S. NIH-bevilling/kontrakt)
- NCI-2014-02380 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- AEWS1221 (Anden identifikator: CTEP)
- s15-00442
- AEWS1221
- AEWS1221 (Anden identifikator: Children's Oncology Group)
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