Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus amifostine chemoprotection in treating patients who have metastatic or unresectable cancer and who are undergoing peripheral stem cell transplantation.
Brain and Central Nervous System Tumors
Carcinoma of Unknown Primary
Extragonadal Germ Cell Tumor
Head and Neck Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Drug: amifostine trihydrate
Procedure: peripheral blood stem cell transplantation
|Study Design:||Primary Purpose: Treatment|
|Official Title:||High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection|
|Study Start Date:||July 1998|
OBJECTIVES: I. Describe the toxic effects of ifosfamide, carboplatin, and etoposide (ICE) with amifostine in patients with metastatic or locally unresectable malignancies who are undergoing peripheral stem cell transplantation. II. Describe the pharmacokinetic profile for ifosfamide and its metabolites in patients receiving the maximum tolerated dose of ICE with amifostine. III. Compare the toxic effects of this study with the toxic effects observed on protocol 94-078. IV. Compare the pharmacokinetics of ifosfamide on this study with the pharmacokinetics observed on protocol 94-078.
OUTLINE: Patients undergo peripheral blood stem cell (PBSC) harvest on day -8, followed by ifosfamide IV, carboplatin IV, and etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4. Patients receive amifostine IV twice a day on days -7 to -3. PBSCs are reinfused on day 0. Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover. Patients are followed monthly for the first 2 months and then for survival.
PROJECTED ACCRUAL: A total of 25 evaluable patients will be accrued for this study within 19 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003657
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Paul G.G. Richardson, MD||Dana-Farber Cancer Institute|