Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00412581|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : April 29, 2016
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.
- To define the recommended Phase II doses of Lenalidomide and DTIC when administered as combination therapy.
- To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC.
- To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Lenalidomide Drug: Dacarbazine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Safety Study of the Combination of Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy (CC-5013-MEL-003)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
|Experimental: Lenalidomide + Dacarbazine||
25 mg by mouth daily for 2 weeks, followed by 1 week of rest.
Other Names:Drug: Dacarbazine
600 mg/m^2 intravenously on Day 1 of every study cycle.
Other Name: DTIC
- To find out the highest safe dose of DTIC that can be given in combination with a steady dose of Lenalidomide, to patients with malignant melanoma that has spread to other parts of the body and has not been treated with chemotherapy. [ Time Frame: 2.5 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412581
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Agop Y. Bedikian, MD||M.D. Anderson Cancer Center|