Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
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Purpose
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,
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Temozolomide (TMZ) |
Phase 2 |
| Study Type: | Interventional |
| 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 |
- affect on tumor growth relative to treatment [ Time Frame: 8 weeks x 6 weeks followed by 2 weeks off. ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 - Temozolomide (TMZ) |
Drug: Temozolomide (TMZ)
One group treatment study
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Paul Chapman, MD, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00591370 History of Changes |
| Other Study ID Numbers: | 04-138 |
| Study First Received: | December 26, 2007 |
| Last Updated: | November 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage III or IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013