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.
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.
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
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There are 107 Locations for this study
Birmingham Alabama, 35294, United States
Mobile Alabama, 36688, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92093, United States
Palo Alto California, 94304, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
San Diego California, 92120, United States
San Diego California, 92123, United States
San Diego California, 92134, United States
Santa Clara California, 95051, United States
Stanford California, 94305, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20307, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Miami Florida, 33155, United States
Miami Florida, 33176, United States
Orlando Florida, 32803, United States
Tampa Florida, 33682, United States
West Palm Beach Florida, 33407, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60614, United States
Oak Lawn Illinois, 60453, United States
Peoria Illinois, 61637, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Portland Maine, 04101, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Columbia Missouri, 65212, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14263, United States
New Hyde Park New York, 11042, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Syracuse New York, 13210, United States
Asheville North Carolina, 28801, United States
Charlotte North Carolina, 28232, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27157, United States
Oklahoma City Oklahoma, 73126, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97213, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19134, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Johnson City Tennessee, 37614, United States
Memphis Tennessee, 38105, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Fort Worth Texas, 76104, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78284, United States
Temple Texas, 76508, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24029, United States
Tacoma Washington, 98431, United States
Charleston West Virginia, 25304, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54307, United States
Milwaukee Wisconsin, 53226, United States
Parkville Victoria, 3052, Australia
Calgary Alberta, T2T 5, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8N 3, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H3T 1, Canada
Sainte Foy Quebec, GIV 4, Canada
Groningen , 9713 , Netherlands
Santurce , 00912, Puerto Rico
Bern , CH 30, Switzerland
Geneva , 1211, Switzerland
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