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) of TPI 287 in Combination with Temodar [ Time Frame: 28 day study cycle ] [ Designated as safety issue: Yes ]
MTD is highest dose level in which 6 patients treated with at most 1 experiencing dose limiting toxicity (DLT).
Maximum Tolerated Dose (MTD), measured by clinical and laboratory adverse events.
- Progression-Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Response rate provided along with a 95% credible interval. Logistic regression models used to assess the association between progression-free survival at 6 months and covariates of interest. Additionally, Cox proportional hazards regression models will be fit to model the association between progression-free survival and the same covariates. Simon's minimax two-stage design used to evaluate the response rate.
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||February 2016 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01067066
|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|