- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006102
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.
II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.
III. Determine the toxicity of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor [PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).
Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australia, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6006
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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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 Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Children's Hospital
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London, Ontario, Canada, N6C 2V5
- Children's Hospital of Western Ontario
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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, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canada, H3H 1P3
- McGill University Health Center - Montreal Children's Hospital
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Sainte-Foy, Quebec, Canada, G1V 4G2
- Laval University Medical Center
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Groningen, Netherlands, 9700 RB
- Academisch Ziekenhuis Groningen
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Auckland, New Zealand
- Starship Children's Hospital
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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Bern, Switzerland, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Switzerland, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Switzerland, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, United States, 36604
- University of South Alabama Medical Center
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Arizona
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Phoenix, Arizona, United States, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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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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Downey, California, United States, 90242
- Southern California Permanente Medical Group
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, United States, 93638-8762
- Children's Hospital Central California
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Oakland, California, United States, 94609-1809
- Children's Hospital of Oakland
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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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 at Stanford
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Sacramento, California, United States, 95816
- Sutter Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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San Diego, California, United States, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Diego, California, United States, 92123-4282
- Children's Hospital San Diego
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San Francisco, California, United States, 94115
- Kaiser Permanente Medical Center - San Francisco Geary Campus
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San Francisco, California, United States, 94143-0128
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, United States, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, United States, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, United States, 80218
- Presbyterian-St Luke's Medical Center
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Denver, Colorado, United States, 80218
- Children's Hospital of Denver
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Connecticut
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Farmington, Connecticut, United States, 06360-7106
- University of Connecticut Health Center
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New Haven, Connecticut, United States, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, United States, 19899
- Alfred I. Dupont Institute
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward General Medical Center
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Fort Myers, Florida, United States, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, United States, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Hollywood, Florida, United States, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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Miami, Florida, United States, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, United States, 33136
- University of Miami-Jackson Memorial Hospital
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Miami, Florida, United States, 33155-4069
- Miami Children's Hospital
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic-Orlando
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Orlando, Florida, United States, 32803
- Walt Disney Memorial Cancer Institute at Florida Hospital
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Pensacola, Florida, United States, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, United States, 33701
- All Children's Hospital
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Tampa, Florida, United States, 33677-4227
- Tampa Children's Hospital
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West Palm Beach, Florida, United States, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, United States, 30342
- Children's Healthcare of Atlanta - Scottish Rite
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Augusta, Georgia, United States, 30912-4000
- Medical College of Georgia Comprehensive Cancer Center
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Macon, Georgia, United States, 31201
- Medical Center of Central Georgia
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, United States, 83712
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, United States, 60601
- University of Chicago Cancer Research Center
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Oak Lawn, Illinois, United States, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, United States, 60068-1174
- Lutheran General Hospital
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, United States, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46260
- St. Vincent Hospital and Health Care Center
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Iowa
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Des Moines, Iowa, United States, 50308
- Raymond Blank Memorial Hospital for Children
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Kansas
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Wichita, Kansas, United States, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40536-0284
- Albert B. Chandler Medical Center, University of Kentucky
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Louisville, Kentucky, United States, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70118
- Children's Hospital of New Orleans
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, United States, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney kimmel comprehensive cancer center at johns hopkins
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Baltimore, Maryland, United States, 21201-1595
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, United States, 21225
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, United States, 01107
- Baystate Medical Center
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, United States, 48236
- St. John Hospital and Medical Center
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East Lansing, Michigan, United States, 48824
- Michigan State University
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Royal Oak, Michigan, United States, 48073-6769
- William Beaumont Hospital
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Minnesota
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Duluth, Minnesota, United States, 55805-1983
- St. Mary's/Duluth Clinic Cancer Center
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, United States, 55102
- Children's Hospitals and Clinics - Minnesota
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia Hospital and Clinics
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, United States, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, United States, 68198-2168
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89109-2306
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Livingston, New Jersey, United States, 07039
- St. Barnabas Medical Center
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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Newark, New Jersey, United States, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, United States, 07901
- Atlantic Health System
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, United States, 10461
- Albert Einstein Clinical Cancer Center
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Brooklyn, New York, United States, 11219
- Maimonides Medical Center
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Brooklyn, New York, United States, 11201
- Brooklyn Hospital Center
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Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn College of Medicine
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Brooklyn, New York, United States, 11212
- Brookdale University Hospital and Medical Center
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New Hyde Park, New York, United States, 11042
- Schneider Children's Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, United States, 10021-4885
- New York Presbyterian Hospital - Cornell Campus
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center
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Stony Brook, New York, United States, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Valhalla, New York, United States, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission St. Joseph's Health System
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Charlotte, North Carolina, United States, 28232-2861
- Carolinas Medical Center
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Charlotte, North Carolina, United States, 28233
- Presbyterian Healthcare
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, United States, 27858-4354
- East Carolina University School of Medicine
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North Dakota
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Fargo, North Dakota, United States, 58103-4940
- Dakota Cancer Institute
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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, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43205-2696
- Children's Hospital of Columbus
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Dayton, Ohio, United States, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, United States, 43601
- Toledo Children's Hospital
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Youngstown, Ohio, United States, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Children's Hospital of Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center
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Oregon
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Portland, Oregon, United States, 97201-3098
- Doernbecher Children's Hospital
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, United States, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, United States, 57105-1080
- Avera Cancer Institute
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Sioux Falls, South Dakota, United States, 57117
- Sioux Valley Hospital
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Tennessee
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Johnson City, Tennessee, United States, 37604
- East Tennessee State University Cancer Center at JCMC
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Knoxville, Tennessee, United States, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, United States, 38105-2794
- St. Jude Children's Research Hospital
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, United States, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, United States, 77555-0361
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, United States, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Lubbock, Texas, United States, 79410
- Covenant Children's Hospital
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San Antonio, Texas, United States, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229-3902
- Methodist Health Care System
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center at the University of Virginia
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Falls Church, Virginia, United States, 22042-3300
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, United States, 23708-5100
- Naval Medical Center, Portsmouth
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Richmond, Virginia, United States, 23298-0037
- Massey Cancer Center
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Roanoke, Virginia, United States, 24029
- Carilion Medical Center for Children
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Washington
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Seattle, Washington, United States, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, United States, 98112
- Group Health Cooperative
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Spokane, Washington, United States, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25302
- West Virginia University - Charleston
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Huntington, West Virginia, United States, 25701
- Cabell-Huntington Hospital, Inc
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Morgantown, West Virginia, United States, 26506-9300
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, United States, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, United States, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53792-6164
- Medical College of Ohio Hospital
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Marshfield, Wisconsin, United States, 54449-5772
- Marshfield Clinic
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Milwaukee, Wisconsin, United States, 53226
- Midwest Children's Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors
- Neuroblastoma
- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
- Osteosarcoma (closed to accrual as of 5/19/03)
- Rhabdomyosarcoma
- Other extracranial solid tumors
CNS/brain tumors:
- Medulloblastoma/PNET
- Ependymoma
- Brainstem glioma
- Other CNS tumors
- Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
Histologically or cytologically proven non-Hodgkin's lymphoma
- Refractory to standard treatment and no curative therapy available
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 21 and under at time of original diagnosis
Performance status:
- Karnofsky 50-100% in patients over 10 years of age
- Lansky 50-100% in patients age 10 and under
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 75,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin normal for age
- SGPT less than 2.5 times upper limit of normal
- Amylase normal
- Lipase normal
Renal:
- Creatinine normal for age OR
- Glomerular filtration rate at least 60 mL/min
Other:
- No concurrent uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
Chemotherapy:
- At least 6 weeks since prior nitrosourea and recovered
- Recovered from any other prior chemotherapy
- No more than two prior chemotherapy regimens
Endocrine therapy:
- CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry
Radiotherapy:
- At least 6 weeks since prior extended radiotherapy and recovered
- No prior total body irradiation
Surgery:
- Prior radiosurgery allowed
Other:
No concurrent use of the following foods or medications:
- Grapefruit juice
- Erythromycin
- Azithromycin
- Clarithromycin
- Rifampin and analogues
- Fluconazole
- Ketoconazole
- Itraconazole
- Cimetidine
- Cannabinoids (marijuana or dronabinol)
- Leukotriene inhibitors (e.g., zafirlukast and zileuton)
- No other concurrent anticancer or investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I
Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor [PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors). Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity. |
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anne-Marie Langevin, MD, The University of Texas Health Science Center at San Antonio
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- childhood high-grade cerebral astrocytoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- stage III childhood large cell lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- childhood infratentorial ependymoma
- recurrent childhood lymphoblastic lymphoma
- childhood supratentorial ependymoma
- childhood oligodendroglioma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- recurrent childhood brain stem glioma
- recurrent childhood medulloblastoma
- recurrent childhood visual pathway and hypothalamic glioma
- childhood craniopharyngioma
- childhood central nervous system germ cell tumor
- childhood choroid plexus tumor
- childhood grade I meningioma
- childhood grade II meningioma
- childhood grade III meningioma
- intraocular retinoblastoma
- extraocular retinoblastoma
- recurrent retinoblastoma
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Neoplasms
- Lymphoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroblastoma
- Retinoblastoma
Other Study ID Numbers
- NCI-2012-01851
- COG-P9963
- CDR0000068111 (REGISTRY: PDQ (Physician Data Query))
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.
Clinical Trials on Sarcoma
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Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
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Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
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National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
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Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
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Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
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David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
Clinical Trials on becatecarin
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedNeuroblastomaUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Completed
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Northwestern UniversityNational Cancer Institute (NCI)TerminatedOvarian CancerUnited States
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National Cancer Institute (NCI)CompletedColorectal CancerUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed
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National Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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National Cancer Institute (NCI)CompletedLymphoma | Small Intestine Cancer | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedLiver Cancer | Gallbladder Cancer | Extrahepatic Bile Duct CancerUnited States
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National Cancer Institute (NCI)CompletedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Recurrent Breast CancerUnited States
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National Cancer Institute (NCI)CompletedChronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) and other conditionsUnited States