A Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles in Patients With Castration-resistant Prostate Cancer (CRPC) (MEL-CAP)
The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in combination with a transplant of patients' own blood stem cells for a maximum of three cycles.
In a recently completed small Phase I study looking at the use of higher doses of intravenous Melphalan with the combination of lenograstim (a drug that stimulates bone marrow to produce white blood cells helping to fight infection) and patients' own blood infusion over 4 cycles of treatment has proved encouraging. The results of this study showed rapid improvement in pain and a fall in circulating tumour cells within two weeks of starting Melphalan. However, slow platelet recovery after the fourth cycle meant longer periods of platelet transfusion. For this trial we intend to assess the efficacy of an intensified intravenous Melphalan with transplant of patients' own blood stem cells over a shorter time period. This study will involve approximately 39 patients over a 3 year period.
Study Type: Interventional
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles in Patients With Castration-resistant Prostate Cancer (CRPC)
Estimated Enrollment: 39
Study Start Date: December 2012
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
- Experimental: Melphalan and lenograstim
|Study start date||2012-12-01|