drugset / Trial / NCT00052884
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Phase 1
Terminated
8 enrolled
Eastern Cooperative Oncology Group
National Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
Timeline
- Start
- 2004-01-22
- Primary completion
- 2007-09
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 120 mg/m2 | Intravenous |
| Background | amifostine | Unknown | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |