Status:
COMPLETED
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Melanoma
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators hav...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologic proof of melanoma reviewed and confirmed at MSKCC
- Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
- Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
- No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
- No other concurrent chemotherapy, immunotherapy, or radiotherapy
- ECOG performance status ≤ 1
- Adequate organ function defined as follows: ANC \>1500/mm3, Platelets \>130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft \& Gault).
- Adequate cardiac function to tolerate the hydration needed for cisplatin administration.
Exclusion
- History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
- Uveal melanoma primary
- Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00885534
Start Date
April 1 2009
End Date
October 1 2013
Last Update
May 6 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065