A Phase I/II Study of TPI 287 - Temozolomide Combination in Melanoma
The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma.
The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Open-Label Study TPI 287 in Combination With Temozolomide in Patients With Metastatic Melanoma|
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 day study cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: TPI 287 + Temodar
Starting dose of TPI 287 90 mg/m^2 IV on Days 1, 8, 15 + Temozolomide (Temodar) PO at 85 mg/m^2 on Days 1-5.
Drug: TPI 287
Starting dose cycle 1, 90 mg/m2 by vein (IV) on Days 1, 8, 15 (+/- 1 day)Drug: Temodar (Temozolomide)
Starting dose cycle 1, 85 mg/m^2 by mouth (PO) daily, Day 1 to 5.
Other Name: Temozolomide
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Agop Y. Bedikian, MD, BS||UT MD Anderson Cancer Center|