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BMS-247550 in Treating Patients With Stage IV Melanoma
This study has been completed.
Study NCT00036764   Information provided by National Cancer Institute (NCI)
First Received: May 13, 2002   Last Updated: July 23, 2008   History of Changes

May 13, 2002
July 23, 2008
February 2002
 
 
 
Complete list of historical versions of study NCT00036764 on ClinicalTrials.gov Archive Site
 
 
 
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma.

OBJECTIVES:

  • Determine the efficacy of BMS-247550 in patients with stage IV melanoma.
  • 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.

PROJECTED ACCRUAL: A total of 23-88 patients (11-50 who have not received prior chemotherapy and 12-38 who have received prior chemotherapy) will be accrued for this study within 24 months.

Phase II
Interventional
Treatment
Melanoma (Skin)
Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV melanoma
  • At least 1 measurable lesion

    • Greater than 20 mm by conventional techniques OR
    • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • 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 CONCURRENT THERAPY:

Biologic therapy:

  • Prior vaccine therapy allowed
  • Prior immunotherapy (e.g., interleukin-2 or interferon) allowed

Chemotherapy:

  • Stratum I:

    • No prior chemotherapy
  • Stratum II:

    • No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide)

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:

  • 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,   Australia
 
NCT00036764
 
CDR0000069320, NYU-0057, NCI-4470
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Anna Pavlick, MD New York University School of Medicine
National Cancer Institute (NCI)
June 2003

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