Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Temozolomide (TMZ)
Sponsored by

About this trial
This is an interventional treatment trial for Melanoma focused on measuring Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage, III or IV melanoma
Eligibility Criteria
Inclusion Criteria:
- Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
- Histologic proof of melanoma reviewed and confirmed at MSKCC
- Measurable disease (RECIST criteria)
- No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
- No other concurrent chemotherapy, immunotherapy, or radiotherapy
- Karnofsky performance status ≥ 60
- Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
- Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).
Exclusion Criteria:
- History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
- Uveal or mucosal melanoma primary
- Frequent vomiting or medical conditions that could interfere with oral medication intake
- Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
- History of HIV infection even if on HAART
- Immunosuppressive drugs
- High dose vitamins and herbs
- Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 - Temozolomide (TMZ)
Arm Description
Outcomes
Primary Outcome Measures
Determine the Overall Objective Response Rate (CR and PR).
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.
Secondary Outcome Measures
Overall Survival
Overall survival at 18 months post treatment
Duration of Objective Clinical Responses
Duration of Response (Objective Clinical Responses)
Full Information
NCT ID
NCT00591370
First Posted
December 26, 2007
Last Updated
July 10, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00591370
Brief Title
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Official Title
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Schering-Plough
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage, III or IV melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 - Temozolomide (TMZ)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Temozolomide (TMZ)
Intervention Description
One group treatment study
Primary Outcome Measure Information:
Title
Determine the Overall Objective Response Rate (CR and PR).
Description
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.
Time Frame
From start of treatment through 24 weeks after ending treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival at 18 months post treatment
Time Frame
18 months after ending treatment
Title
Duration of Objective Clinical Responses
Description
Duration of Response (Objective Clinical Responses)
Time Frame
24 weeks after ending treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
Histologic proof of melanoma reviewed and confirmed at MSKCC
Measurable disease (RECIST criteria)
No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
No other concurrent chemotherapy, immunotherapy, or radiotherapy
Karnofsky performance status ≥ 60
Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).
Exclusion Criteria:
History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
Uveal or mucosal melanoma primary
Frequent vomiting or medical conditions that could interfere with oral medication intake
Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
History of HIV infection even if on HAART
Immunosuppressive drugs
High dose vitamins and herbs
Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chapman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
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