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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Schering-Plough
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00591370

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 II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment
Official Title:	Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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
1 - Temozolomide (TMZ): Experimental	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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591370

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Schering-Plough

Investigators

Principal Investigator:

Paul Chapman, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Paul Chapman, MD )
Study ID Numbers:	04-138
Study First Received:	December 26, 2007
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00591370
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

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Temozolomide
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009