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

May 13, 2002
January 24, 2013
February 2002
August 2004   (final data collection date for primary outcome measure)
Response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
The 95% confidence intervals will be provided.
Not Provided
Complete list of historical versions of study NCT00036764 on ClinicalTrials.gov 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 ] [ 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.
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036764
NCI-2012-02464, NYU-0057, N01CM17103, CDR0000069320
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
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