Expired Study
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New York, New York 10016


Purpose:

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die


Study summary:

OBJECTIVES: I. Determine the efficacy of BMS-247550 in patients with stage IV melanoma. II. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide). Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed stage IV melanoma - At least 1 measurable lesion - Greater than 20 mm by conventional techniques - Greater than 10 mm by spiral CT scan - Known brain metastases allowed if all of the following criteria are met: - Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy - Stable at time of study - No mass effect present radiologically - No concurrent steroids to control symptoms of brain metastases - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - At least 3 months - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) - Creatinine no greater than 1.5 times ULN - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL - No pre-existing grade 2 or greater peripheral neuropathy - No HIV-positive patients receiving combination antiretroviral therapy - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness that would preclude study - Prior vaccine therapy allowed - Prior immunotherapy (e.g., interleukin-2 or interferon) allowed - Stratum I: - No prior chemotherapy - Stratum II: - No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide) - See Disease Characteristics - See Disease Characteristics - Prior limb-perfusion therapy allowed (stratum II) - No other concurrent investigational or commercial agents or therapies intended to treat malignancy - No concurrent Hypericum perforatum


NCT ID:

NCT00036764


Primary Contact:

Principal Investigator
Anna Pavlick
New York University Clinical Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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