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Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Skin Cancer

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Trial Information

Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify genetic variates of response to CVT chemotherapy.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Paul Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-017

NCT ID:

NCT00885534

Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Melanoma
  • Skin Cancer
  • skin cancer
  • CISPLATIN
  • TEMOZOLOMIDE
  • VINBLASTINE
  • 09-017
  • Skin Neoplasms
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021