Trials / Completed
CompletedNCT00003425
Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect
Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- University of Kentucky · Academic / Other
- Sex
- All
- Age
- 14 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II. Determine the complete response rate, event free survival, overall survival, and nonrelapse mortality in this patient population. OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is given until cytapheresis is completed. Patients receive high dose melphalan according to an escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. After the MTD of high dose melphalan is determined, additional patients are treated at this dose level. Patients are followed at days 30, 100, 365, and yearly thereafter. PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued for this study.
Conditions
- Breast Cancer
- Leukemia
- Lymphoma
- Neuroblastoma
- Ovarian Cancer
- Sarcoma
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | filgrastim | |
| DRUG | amifostine trihydrate | |
| DRUG | cyclophosphamide | |
| DRUG | melphalan | |
| PROCEDURE | peripheral blood stem cell transplantation |
Timeline
- Start date
- 1997-12-01
- Primary completion
- 2002-07-01
- First posted
- 2004-02-20
- Last updated
- 2013-04-26
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003425. Inclusion in this directory is not an endorsement.