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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Melanoma; Stage IV Melanoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: ixabepilone; Other: pharmacogenomic studies

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016-4760
      • New York University Clinical Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: laboratory biomarker analysis; Correlative studies; Drug: ixabepilone; Given IV; Other Names: BMS-247550; epothilone B lactam; Ixempra; Other: pharmacogenomic studies; Correlative studies; Other Names: Pharmacogenomic Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	The 95% confidence intervals will be provided.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of related toxicities graded according to the revised NCI CTC version 2.0	Related toxicities will be described.	Up to 2 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Anna Pavlick, New York University Clinical Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: May 13, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones; Epothilone B
• Other Study ID Numbers: NCI-2012-02464; N01CM17103 (U.S. NIH Grant/Contract); NYU-0057; CDR0000069320 (Registry Identifier: PDQ (Physician Data Query))