- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01614795
Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma
A Phase II Study of Cixutumumab (IMC-A12) in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors
Study Overview
Status
Conditions
- Rhabdomyosarcoma
- Recurrent Osteosarcoma
- Recurrent Childhood Rhabdomyosarcoma
- Previously Treated Childhood Rhabdomyosarcoma
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Childhood Angiosarcoma
- Childhood Epithelioid Sarcoma
- Childhood Fibrosarcoma
- Childhood Leiomyosarcoma
- Childhood Liposarcoma
- Childhood Synovial Sarcoma
- Childhood Alveolar Soft Part Sarcoma
- Childhood Gliosarcoma
- Childhood Malignant Peripheral Nerve Sheath Tumor
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the objective response rate to the combination of cixutumumab and temsirolimus in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma.
II. To further describe the toxicities (including dose-limiting toxicities) of cixutumumab and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
I. To assess the progression-free survival for patients treated in each disease stratum with this drug combination.
II. To assess the incidence of insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) pathway activation in archival tumor material, and correlate with response.
III. To evaluate minimal residual disease and IGF-1R tumor cell expression in the blood and bone marrow of Ewing sarcoma patients using flow cytometry.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (osteosarcoma vs Ewing sarcoma/PNET vs rhabdomyosarcoma vs non-rhabdomyosarcoma soft tissue sarcoma).
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples from most recent biopsy are collected and analyzed for IGF-1R, insulin receptor, AKT, ERK, mTOR, and S6 kinase pathway activation by immunohistochemistry (IHC) and banked for future correlative studies. Blood and bone marrow samples, from patients with Ewing sarcoma, may be collected at baseline and periodically during treatment for minimal residual disease analysis by flow cytometry.
After completion of study treatment, patients are followed up periodically for 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Quebec
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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, United States, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Oakland, California, United States, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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San Francisco, California, United States, 94143
- UCSF Medical Center-Parnassus
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Florida
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Fort Myers, Florida, United States, 33901
- Lee Memorial Health System
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, United States, 33155
- Nicklaus Children's Hospital
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Orlando, Florida, United States, 32803
- Florida Hospital Orlando
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic - Orlando
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Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
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Saint Petersburg, Florida, United States, 33701
- Johns Hopkins All Children's Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston
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Savannah, Georgia, United States, 31404
- Memorial University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46260
- Saint Vincent Hospital and Health Care Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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Maryland
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64108
- The Childrens Mercy Hospital
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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Nebraska
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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Summit, New Jersey, United States, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10032
- Columbia University/Herbert Irving Cancer Center
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Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Toledo, Ohio, United States, 43608
- Mercy Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97227
- Legacy Emanuel Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health Richland
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Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
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Tennessee
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Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, United States, 98405
- Mary Bridge Children's Hospital and Health Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, are eligible:
- Osteosarcoma
- Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Rhabdomyosarcoma
- Non-rhabdomyosarcoma soft tissue sarcoma
- Patients must have had histologic verification of malignancy at original diagnosis or relapse
All patients are required to submit archival tumor samples for immunohistochemical analysis (either paraffin-embedded tumor blocks or unstained slides)
- Tissue samples collected at original diagnosis or at relapse or at any subsequent resections or biopsies should be available and ready for shipment to the Biopathology Center (BPC) at time of study enrollment; the samples are required even if tissue samples have previously been sent to the BPC for other purposes or studies; blocks or slides should be shipped to the BPC within 7 days of study enrollment
Patients must have radiographically measurable disease
- Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
The following do not qualify as measurable disease:
- Malignant fluid collections (e.g., ascites, pleural effusions)
- Bone marrow infiltration
- Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
- Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
- Previously radiated lesions that have not demonstrated clear progression post radiation
- Leptomeningeal lesions that do not meet the measurements noted above
- Patient?s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Patients with known central nervous system metastases are excluded unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
Patients must have a Lansky or Karnofsky performance status score of ? 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients ? 16 years of age
- Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
For patients with solid tumors without bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) ? 1,000/?L
- Platelet count ? 100,000/?L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
- Hemoglobin ? 8.0 g/dL (may receive red blood cell [RBC] transfusions)
For patients with solid tumors and known bone marrow metastatic disease:
- ANC ? 750/?L
- Platelet count ? 50,000/?L (may receive platelet transfusions)
Hemoglobin ? 8.0 g/dL (may receive RBC transfusions)
- For patients with known bone marrow metastatic disease, transfusions are permitted to meet both platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions
Creatinine clearance or radioisotope GFR ? 70 mL/min OR a serum creatinine based on age/gender as follows:
- 0.6 mg/dL (1 to < 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to < 16 years of age)
- 1.7 mg/dL (males) or 1.4 mg/dL (females) ( ? 16 years of age)
- Total bilirubin ? 1.5 times upper limit of normal (ULN)
- Serum glutamic pyruvate transaminase(SGPT) (alanine aminotransaminase [ALT]) ? 2.5 times ULN (for the purpose of this study, the ULN for SGPT is 45 U/L)
- Serum albumin ? 2 g/dL
- Patients with seizure disorder may be enrolled if receiving non-enzyme-inducing anticonvulsants and well controlled
- Patients with known type I or type II diabetes mellitus are not eligible
- Serum glucose values must be within the normal limits for age; if the initial blood glucose is a random sample that is outside normal limits, then a follow-up fasting blood glucose should be obtained and must be within the normal limits for age
- Serum cholesterol levels must be < grade 2 (< 300 mg/dL), and serum triglyceride levels must be < grade 2 (< 2.5 times ULN)
- Patients who are pregnant or breast-feeding are not eligible for this study
- Negative pregnancy tests must be obtained in girls who are post-menarchal
- Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study and for 3 months after the last dose of cixutumumab
- Patients who have an uncontrolled infection are not eligible
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible
- See Disease Characteristics
- There is no limit to the number of prior treatment regimens; however, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
- Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea)
- At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim
- At least 7 days must have elapsed since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur
- At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
- ? 2 weeks must have elapsed since local palliative radiotherapy (XRT) (small port); 3 months must have elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if therapeutic doses of metaiodobenzylguanidine(MIBG) or other substantial bone marrow irradiation was given
- No evidence of active graft-vs-host disease and 2 months must have elapsed since stem cell transplant or rescue
- Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if Neulasta?)
- Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible
- Patients who are currently receiving another investigational drug are not eligible
- Patients who are currently receiving other anti-cancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy, are not eligible
- Patients receiving insulin or growth hormone therapy are not eligible
- Patients who are receiving enzyme-inducing anticonvulsants are not eligible
- Use of warfarin is not allowed while on study; patients already on warfarin should use alternative anticoagulants while on this study; warfarin must not have been administered within 7 days of starting protocol therapy
- Patients who have received prior therapy targeting IGF-1R with either monoclonal antibodies or small molecule tyrosine kinase inhibitors are NOT eligible
- Prior treatment with mTOR inhibitors (e.g., rapamycin, temsirolimus, everolimus, deforolimus) is NOT allowed
- Patients who have had major surgery within 3 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter or limited tumor biopsy are not considered major surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment (cixutumumab, temsirolimus)
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
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Correlative studies
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame: 6 cycles (168 days)
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Per Response evaluation criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Overall Response (OR)= CR+PR.
The combination of sufficient activity is considered if the true response rate is 35% or greater.
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6 cycles (168 days)
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Number of Cycles of Toxicity
Time Frame: Duration of protocol therapy - Up to 25 cycles (700 days)
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The number of patients-cycles where CTC Version 4 grade 3 or higher increased Alanine aminotransferase was observed
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Duration of protocol therapy - Up to 25 cycles (700 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Interval
Time Frame: 10 months after enrollment
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Percentage Probability of remaining progression-free 5 years after enrollment estimated by the method of Kaplan and Meier
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10 months after enrollment
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Expression Levels of IGF-1R, Insulin Receptor, ERK, RON, and mTOR
Time Frame: Baseline
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Number of patients expressing insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) at levels 0, 1+, 2+, 3+ by immunohistochemistry.
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Baseline
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Number of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Wagner, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neuromuscular Diseases
- Glioma
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Neoplasms, Vascular Tissue
- Neoplasms, Muscle Tissue
- Peripheral Nervous System Neoplasms
- Neoplasms, Adipose Tissue
- Myosarcoma
- Neoplasms, Fibrous Tissue
- Neurofibroma
- Sarcoma
- Recurrence
- Sarcoma, Ewing
- Osteosarcoma
- Gliosarcoma
- Leiomyosarcoma
- Nerve Sheath Neoplasms
- Liposarcoma
- Rhabdomyosarcoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Rhabdomyosarcoma, Embryonal
- Hemangiosarcoma
- Neurofibrosarcoma
- Sarcoma, Synovial
- Sarcoma, Alveolar Soft Part
- Fibrosarcoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Antibodies, Monoclonal
- Sirolimus
Other Study ID Numbers
- NCI-2012-01971 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA098543 (U.S. NIH Grant/Contract)
- ADVL1221 (Other Identifier: CTEP)
- COG-ADVL1221
- CDR0000734871
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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