Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
RATIONALE: Drugs used in chemotherapy 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: Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.
|Breast Cancer Drug/Agent Toxicity by Tissue/Organ Lung Cancer Lymphoma Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: sargramostim Drug: amifostine trihydrate Drug: cisplatin Drug: cyclophosphamide Drug: etoposide||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase II, Open-Label, Trial Evaluating the Efficacy of Amifostine in Patients With Cancers Receiving Outpatient Dose-intensive Cyclophosphamide, Etoposide, and Cisplatin (DICEP) Chemotherapy|
- duration of neutropenia [ Time Frame: 30 days ]number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy
- incidence of nephrotoxicity [ Time Frame: 30 days ]decrease in creatinine clearance from baseline after high dose chemotherapy
- incidence of ototoxicity [ Time Frame: 30 days ]change in audiogram from baseline after high dose chemotherapy
|Study Start Date:||February 1998|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of amifostine in enhancing hematopoietic recovery following cyclophosphamide, etoposide, and cisplatin therapy in patients with hematologic malignancies and adult solid tumors.
OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2. Cyclophosphamide is administered over 3 hours on days 0 and 1, intravenous etoposide over 4 hours on days 0, 1, and 2, and cisplatin over 4 hours on days 0, 1, and 2. All patients receive sargramostim (GM-CSF) beginning on day 4. Patients receive a maximum of 2 courses of treatment (with 35-42 days between chemotherapy courses). Patients are followed for 1-5 months after treatment.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003269
|United States, California|
|La Jolla, California, United States, 92037|
|Study Chair:||James R. Mason, MD||Ida M. and Cecil H. Green Cancer Center at Scripps Clinic|