Trials / Completed
CompletedNCT00003269
Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Scripps Health · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Breast Cancer
- Drug/Agent Toxicity by Tissue/Organ
- Lung Cancer
- Lymphoma
- Ovarian Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | sargramostim | |
| DRUG | amifostine trihydrate | |
| DRUG | cisplatin | |
| DRUG | cyclophosphamide | |
| DRUG | etoposide |
Timeline
- Start date
- 1998-02-01
- Primary completion
- 2001-01-01
- Completion
- 2001-01-01
- First posted
- 2004-05-24
- Last updated
- 2011-01-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003269. Inclusion in this directory is not an endorsement.