BMS-247550 in Treating Patients With Stage IV Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Epothilone B; Epothilones

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