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BMS-247550 in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036764
First received: May 13, 2002
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  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


Condition Intervention Phase
Recurrent Melanoma
Stage IV Melanoma
 Drug: ixabepilone
Other: pharmacogenomic studies
Other: laboratory biomarker analysis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Ixabepilone
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The 95% confidence intervals will be provided.


Secondary Outcome Measures:
  • Median time to progression [ Time Frame: Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]
    Median time to progression will be described for each subgroup.

  • Incidence of related toxicities graded according to the revised NCI CTC version 2.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Related toxicities will be described.


Enrollment: 88
Study Start Date: February 2002
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pharmacogenomic Study
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036764

Locations
United States, New York
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
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00036764     History of Changes
Other Study ID Numbers: NCI-2012-02464, NYU-0057, N01CM17103, CDR0000069320
Study First Received: May 13, 2002
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Epothilone B
 Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013