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Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591370
First received: December 26, 2007
Last updated: November 10, 2008
Last verified: November 2008

December 26, 2007
November 10, 2008
January 2005
June 2008   (final data collection date for primary outcome measure)
affect on tumor growth relative to treatment [ Time Frame: 8 weeks x 6 weeks followed by 2 weeks off. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00591370 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
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,

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: Temozolomide (TMZ)
One group treatment study
Experimental: 1 - Temozolomide (TMZ)
Intervention: Drug: Temozolomide (TMZ)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591370
04-138
Yes
Paul Chapman, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Schering-Plough
Principal Investigator: Paul Chapman, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP