BMS-247550 in Treating Patients With Stage IV Melanoma

Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036764
• Other study ID #: NCI-2012-02464
• Secondary ID: NYU-0057N01CM171
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2002
• Last updated: January 24, 2013
• Start date: February 2002

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IV Melanoma

Intervention

Drug:
• ixabepilone
Given IV

Other:
• pharmacogenomic studies
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	New York University Clinical Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	The 95% confidence intervals will be provided.	Up to 2 years	No
Secondary	Median time to progression	Median time to progression will be described for each subgroup.	Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years	No
Secondary	Incidence of related toxicities graded according to the revised NCI CTC version 2.0	Related toxicities will be described.	Up to 2 years	Yes