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BMS-247550 in Treating Patients With Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036764
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 25, 2013
Information provided by (Responsible Party):
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

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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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 : February 2002
Actual Primary Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ixabepilone

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 Name: Pharmacogenomic Study

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 2 years ]
    The 95% confidence intervals will be provided.

Secondary Outcome Measures :
  1. 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 ]
    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 [ Time Frame: Up to 2 years ]
    Related toxicities will be described.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036764

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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)
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Principal Investigator: Anna Pavlick New York University Clinical Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00036764    
Other Study ID Numbers: NCI-2012-02464
N01CM17103 ( U.S. NIH Grant/Contract )
CDR0000069320 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents