BMS-247550 in Treating Patients With Stage IV Melanoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Recurrent Melanoma; Stage IV Melanoma

Treatments: Other: pharmacogenomic studies; Drug: ixabepilone; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00036764

NYU-0057

N01CM17103 (U.S. NIH Grant/Contract)

NCI-2012-02464

CDR0000069320 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Drug: ixabepilone

Other: pharmacogenomic studies