Ovarian Cancer Clinical Trial

Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Summary

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

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Full Description

OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin, etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant, extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049/CCG-8881 with the same combination chemotherapy. III. Determine the response rate of patients treated with this regimen.

OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. Patients who have no disease after 4 courses of chemotherapy receive no further treatment. Patients who have residual disease undergo second-look surgery. After surgery, patients who still have active tumor receive 2 additional courses of chemotherapy. Those patients who still have tumor after the 2 additional courses may have a third surgery. Patients are followed every month for 6 months, every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor) Embryonal carcinoma Choriocarcinoma Teratoma with mixed malignant elements (malignant teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I extracranial, extragonadal tumor High-risk disease defined as stage III or IV extragonadal tumors Measurable disease by diagnostic imaging

PATIENT CHARACTERISTICS: Age: Under 15 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 750/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine normal OR Glomerular filtration rate at least 50% of normal

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00003811

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 107 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
University of California San Diego Cancer Center
La Jolla California, 92093, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto California, 94304, United States
Sutter Cancer Center
Sacramento California, 95816, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Children's Hospital and Health Center
San Diego California, 92123, United States
Naval Medical Center - San Diego
San Diego California, 92134, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California, 95051, United States
Stanford University Medical Center
Stanford California, 94305, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Shands Hospital and Clinics, University of Florida
Gainesville Florida, 32610, United States
Nemours Children's Clinic
Jacksonville Florida, 32207, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
Miami Children's Hospital
Miami Florida, 33155, United States
Baptist Hospital of Miami
Miami Florida, 33176, United States
Walt Disney Memorial Cancer Institute
Orlando Florida, 32803, United States
CCOP - Florida Pediatric
Tampa Florida, 33682, United States
St. Mary's Hospital
West Palm Beach Florida, 33407, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
Children's Memorial Hospital, Chicago
Chicago Illinois, 60614, United States
Hope Children's Hospital
Oak Lawn Illinois, 60453, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Portland Maine, 04101, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Boston Floating Hospital Infants and Children
Boston Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
St. John's Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
University of Missouri-Columbia Hospital and Clinics
Columbia Missouri, 65212, United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
University of New Mexico School of Medicine
Albuquerque New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Schneider Children's Hospital
New Hyde Park New York, 11042, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Mission Saint Joseph's Health System
Asheville North Carolina, 28801, United States
Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Presbyterian Healthcare
Charlotte North Carolina, 28233, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
East Carolina University School of Medicine
Greenville North Carolina, 27858, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Oklahoma Memorial Hospital
Oklahoma City Oklahoma, 73126, United States
Natalie Warren Bryant Cancer Center
Tulsa Oklahoma, 74136, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
St. Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Children's Hospital of Greenville Hospital System
Greenville South Carolina, 29605, United States
James H. Quillen College of Medicine
Johnson City Tennessee, 37614, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas, 76104, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Baylor College of Medicine
Houston Texas, 77030, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base Texas, 78236, United States
MBCCOP - South Texas Pediatric
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Scott and White Clinic
Temple Texas, 76508, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Cancer Center at the University of Virginia
Charlottesville Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Naval Medical Center, Portsmouth
Portsmouth Virginia, 23708, United States
Massey Cancer Center
Richmond Virginia, 23298, United States
Carilion Roanoke Community Hospital
Roanoke Virginia, 24029, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Medical School-Charleston
Charleston West Virginia, 25304, United States
West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
St. Vincent Hospital
Green Bay Wisconsin, 54307, United States
Midwest Children's Cancer Center
Milwaukee Wisconsin, 53226, United States
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Alberta Children's Hospital
Calgary Alberta, T2T 5, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Children's Hospital
Hamilton Ontario, L8N 3, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal Quebec, H3H 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Centre Hospitalier de L'Universite Laval
Sainte Foy Quebec, GIV 4, Canada
Academisch Ziekenhuis Groningen
Groningen , 9713 , Netherlands
San Jorge Childrens Hospital
Santurce , 00912, Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern , CH 30, Switzerland
Clinique de Pediatrie
Geneva , 1211, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00003811

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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