Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect
NCT00003425 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2013-04-26
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.
Conditions
- Breast Cancer
- Leukemia
- Lymphoma
- Neuroblastoma
- Ovarian Cancer
- Sarcoma
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
- BIOLOGICAL
- DRUG
-
amifostine trihydrate
- DRUG
- DRUG
-
melphalan
- PROCEDURE
-
peripheral blood stem cell transplantation
Sponsors & Collaborators
-
University of Kentucky
lead OTHER
Principal Investigators
-
Donna E. Reece, MD · Lucille P. Markey Cancer Center at University of Kentucky
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1997-12-31
- Primary Completion
- 2002-07-31
Countries
- United States
Study Locations
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