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BMS-247550 in Treating Patients With Stage IV Melanoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00036764
Collaborator
(none)
88
Enrollment
1
Location
1
Arm

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: ixabepilone
  • Other: pharmacogenomic studies
  • Other: laboratory biomarker analysis
 Phase 2

Detailed Description

OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
Study Start Date :
Feb 1, 2002
Actual Primary Completion Date :
Aug 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

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.

Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra

    • Other: pharmacogenomic studies
    Correlative studies
    Other Names:
  • Pharmacogenomic Study

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [Up to 2 years]

      The 95% confidence intervals will be provided.

    Secondary Outcome Measures

    1. 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.

    2. Incidence of related toxicities graded according to the revised NCI CTC version 2.0 [Up to 2 years]

      Related toxicities will be described.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University Clinical Cancer Center New York New York United States 10016-4760

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Anna Pavlick, New York University Clinical Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00036764
    Other Study ID Numbers:
    • NCI-2012-02464
    • NYU-0057
    • N01CM17103
    • CDR0000069320
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 25, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Melanoma
    Epothilones
    Epothilone B

    Study Results

    No Results Posted as of Jan 25, 2013