drugset / Trial / NCT00003425
Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 1997-12
- Primary completion
- 2002-07
- Completion
- —
Publications
- Results Phillips GL, Meisenberg BR, Reece DE, Adams VR, Badros AZ, Brunner JL, Fenton RG, Filicko J, Grosso DL, Hale GA, Howard DS, Johnson VP, Kniska A, Marshall KW, Mookerjee B, Nath R, Rapoport AP, Sarkodee-Adoo C, Takebe N, Vesole DH, Wagner JL, Flomenberg N. Activity of single-agent melphalan 220-300 mg/m2 with amifostine cytoprotection and autologous hematopoietic stem cell support in non-Hodgkin and Hodgkin lymphoma. Bone Marrow Transplant. 2004 Apr;33(8):781-7. doi: 10.1038/sj.bmt.1704424.
- Skliarova T, Lara-Cabrera ML, Hafstad H, Havnen A, Saether SG, Salvesen O, Vaag J, Torgersen T. Feasibility, acceptability and preliminary evaluation of a user co-facilitated psychoeducational programme: a feasibility proof-of-concept randomised control trial. BMC Psychiatry. 2024 Sep 16;24(1):615. doi: 10.1186/s12888-024-06015-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | amifostine | Unknown | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |