Know Cancer

forgot password

A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma


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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

The 95% confidence intervals will be provided.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Anna Pavlick

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University Clinical Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



New York University Clinical Cancer Center New York, New York  10016