NCT00036764

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

May 13, 2002

Last Update Submit

January 24, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    The 95% confidence intervals will be provided.

    Up to 2 years

Secondary Outcomes (2)

  • Median time to progression

    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

    Up to 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: ixabepiloneOther: pharmacogenomic studiesOther: laboratory biomarker analysis

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra
Treatment
pharmacogenomic studiesOTHER

Correlative studies

Also known as: Pharmacogenomic Study
Treatment
laboratory biomarker analysisOTHER

Correlative studies

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Clinical Cancer Center

New York, New York, 10016-4760, United States

Location

Related Publications (1)

  • 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.

    PMID: 20098694DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

ixabepilonePharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Anna Pavlick

    New York University Clinical Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

August 1, 2004

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)