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)

May 13, 2002
January 27, 2003
January 25, 2013
February 2002
August 2004   (Final data collection date for primary outcome measure)
Response rate [ Time Frame: Up to 2 years ]
The 95% confidence intervals will be provided.
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Complete list of historical versions of study NCT00036764 on Archive Site
  • 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.
  • 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.
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BMS-247550 in Treating Patients With Stage IV Melanoma
A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
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


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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Recurrent Melanoma
  • Stage IV Melanoma
  • 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
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
  • Other: pharmacogenomic studies
  • Other: laboratory biomarker analysis
Ott PA, Hamilton A, Jones A, Haas N, Shore T, Liddell S, Christos PJ, Doyle LA, Millward M, Muggia FM, Pavlick AC. A phase II trial of the epothilone B analog ixabepilone (BMS-247550) in patients with metastatic melanoma. PLoS One. 2010 Jan 20;5(1):e8714. doi: 10.1371/journal.pone.0008714.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
N01CM17103 ( U.S. NIH Grant/Contract )
CDR0000069320 ( Registry Identifier: PDQ (Physician Data Query) )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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Principal Investigator: Anna Pavlick New York University Clinical Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP