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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591370
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : January 22, 2015
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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,

Condition or disease Intervention/treatment Phase
Melanoma Drug: Temozolomide (TMZ) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Study Start Date : January 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: 1 - Temozolomide (TMZ) Drug: Temozolomide (TMZ)
One group treatment study

Primary Outcome Measures :
  1. Determine the Overall Objective Response Rate (CR and PR). [ Time Frame: From start of treatment through 24 weeks after ending treatment ]
    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 :
  1. Overall Survival [ Time Frame: 18 months after ending treatment ]
    Overall survival at 18 months post treatment

  2. Duration of Objective Clinical Responses [ Time Frame: 24 weeks after ending treatment ]
    Duration of Response (Objective Clinical Responses)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591370

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Paul Chapman, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00591370    
Other Study ID Numbers: 04-138
First Posted: January 11, 2008    Key Record Dates
Results First Posted: January 22, 2015
Last Update Posted: November 18, 2015
Last Verified: October 2015
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:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents