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BMS-247550 in Treating Patients With Stage IV Melanoma

Primary Purpose

Recurrent Melanoma, Stage IV Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
pharmacogenomic studies
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University Clinical Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate
The 95% confidence intervals will be provided.

Secondary Outcome Measures

Median time to progression
Median time to progression will be described for each subgroup.
Incidence of related toxicities graded according to the revised NCI CTC version 2.0
Related toxicities will be described.

Full Information

First Posted
May 13, 2002
Last Updated
January 24, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00036764
Brief Title
BMS-247550 in Treating Patients With Stage IV Melanoma
Official Title
A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ixabepilone
Other Intervention Name(s)
BMS-247550, epothilone B lactam, Ixempra
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacogenomic studies
Other Intervention Name(s)
Pharmacogenomic Study
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate
Description
The 95% confidence intervals will be provided.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Median time to progression
Description
Median time to progression will be described for each subgroup.
Time Frame
Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years
Title
Incidence of related toxicities graded according to the revised NCI CTC version 2.0
Description
Related toxicities will be described.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Pavlick
Organizational Affiliation
New York University Clinical Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016-4760
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20098694
Citation
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.
Results Reference
derived

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BMS-247550 in Treating Patients With Stage IV Melanoma

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