Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients.
One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves.
In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage.
We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma|
- Determine the Overall Objective Response Rate (CR and PR). [ Time Frame: From start of treatment through 24 weeks after ending treatment ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Overall Survival [ Time Frame: 18 months after ending treatment ] [ Designated as safety issue: No ]Overall survival at 18 months post treatment
- Duration of Objective Clinical Responses [ Time Frame: 24 weeks after ending treatment ] [ Designated as safety issue: No ]Duration of Response (Objective Clinical Responses)
|Study Start Date:||January 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
|Experimental: 1 - Temozolomide (TMZ)||
Drug: Temozolomide (TMZ)
One group treatment study
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591370
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul Chapman, MD||Memorial Sloan Kettering Cancer Center|