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Sponsors and Collaborators: |
University of Pennsylvania Novartis |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00667953 |
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.
Condition | Intervention | Phase |
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Melanoma Advanced Melanoma |
Drug: Gleevec + Temozolomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma |
Estimated Enrollment: | 56 |
Study Start Date: | January 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A:: Experimental |
Drug: Gleevec + Temozolomide
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
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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:
Responsible Party: | University of Pennsylvania ( Lynn Schuchter, M.D. ) |
Study ID Numbers: | UPCC 02602 |
Study First Received: | April 24, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00667953 |
Health Authority: | United States: Institutional Review Board |
Temzolomide Gleevec Melanoma Advanced melanoma Phase II |
Imatinib Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Temozolomide Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Nevi and Melanomas Antineoplastic Agents, Alkylating Protein Kinase Inhibitors Alkylating Agents Pharmacologic Actions |