Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT00885534
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00885534
Study Brief:
Protocol Section:
NCT00885534