BMS-247550 in Treating Patients With Stage IV Melanoma

NCT ID: NCT00036764

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28

Brief 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

Detailed 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.

Conditions

Recurrent Melanoma; Stage IV Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

pharmacogenomic studies

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

pharmacogenomic studies

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra; Pharmacogenomic Study

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Pavlick

Role: PRINCIPAL_INVESTIGATOR

New York University Clinical Cancer Center

Locations

New York University Clinical Cancer Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20098694 (View on PubMed)

Other Identifiers

NYU-0057

Identifier Type: -

Identifier Source: secondary_id

N01CM17103

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069320

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02464

Identifier Type: -

Identifier Source: org_study_id