BMS-247550 in Treating Patients With Stage IV Melanoma

Phase 2

Completed

• Conditions: Recurrent Melanoma; Stage IV Melanoma
• Interventions: Drug: ixabepilone; Other: pharmacogenomic studies; Other: laboratory biomarker analysis

• Registration Number: NCT00036764
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-05-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	pharmacogenomic studies	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	ixabepilone	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	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Response rate	Up to 2 years	The 95% confidence intervals will be provided.

Secondary Outcome Measures

Name	Time	Method
Median time to progression	Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years	Median time to progression will be described for each subgroup.
Incidence of related toxicities graded according to the revised NCI CTC version 2.0	Up to 2 years	Related toxicities will be described.

Trial Locations

Locations (1)

New York University Clinical Cancer Center; 🇺🇸 New York, New York, United States