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Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma

NCT00412581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-04-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lenalidomide

25 mg by mouth daily for 2 weeks, followed by 1 week of rest.

DRUG

Dacarbazine

600 mg/m\^2 intravenously on Day 1 of every study cycle.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Agop Y. Bedikian, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412581 on ClinicalTrials.gov