Full Text View
Tabular View
No Study Results Posted
Related Studies
BMS-247550 in Treating Patients With Stage IV Melanoma
This study has been completed.
First Received: May 13, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: New York University School of Medicine
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00036764
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: ixabepilone
Phase II

Study Type: Interventional
Study Design: 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:


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

Study Start Date: February 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036764

Locations
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Australia, New South Wales
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, Australia, 2050
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Anna Pavlick, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069320, NYU-0057, NCI-4470
Study First Received: May 13, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00036764     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009