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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00412581 |
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:
Condition | Intervention | Phase |
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Melanoma |
Drug: Lenalidomide Drug: Dacarbazine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 28 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lenalidomide + Dacarbazine
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Drug: Lenalidomide
25 mg PO daily for 2 weeks, followed by 1 week of "rest."
Drug: Dacarbazine
600 mg/m^2 IV on Day 1 of every study cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Agop Y. Bedikian, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Agop Y. Bedikian, MD/Professor ) |
Study ID Numbers: | 2004-0487 |
Study First Received: | December 14, 2006 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00412581 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Melanoma Lenalidomide Dacarbazine |
CC-5013 Revlimid DTIC |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Lenalidomide Neuroepithelioma |
Antineoplastic Agents, Alkylating Nevus Alkylating Agents Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Lenalidomide Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |