Overview

Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2 cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral Lenalidomide in patients with metastatic malignant melanoma previously untreated with systemic chemotherapy. Secondary Objectives: 1. To define the recommended Phase II doses of Lenalidomide and DTIC when administered as combination therapy. 2. To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC. 3. To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Treatments:
Dacarbazine
Lenalidomide
Thalidomide