NCT00087386

Brief Summary

This phase II trial is studying how well tanespimycin works in treating patients with stage III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

July 8, 2004

Last Update Submit

April 9, 2013

Conditions

Recurrent MelanomaStage III MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Response rate (complete and partial response)

    Up to 3 years

Secondary Outcomes (2)

  • Proportion of patients with stable disease

    At 1 year

  • Frequency of toxicities

    Up to 3 years

Study Arms (1)

Treatment (tanespimycin)

EXPERIMENTAL

Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

Drug: tanespimycinOther: laboratory biomarker analysis

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (tanespimycin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (tanespimycin)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed melanoma
  • Stage III or IV disease
  • No primary melanoma of the choroid or mucosa
  • Measurable disease
  • At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
  • Tumor amenable to biopsy (for the first 10 patients in each stratum only)
  • Patients must have measurable disease in addition to the tumor(s) to be biopsied
  • No brain or epidural metastases
  • Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for \>= 6 months
  • Performance status - Karnofsky 60-100%
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count \>= 1,500/mm\^3
  • Platelet count \>= 100,000/mm\^3
  • WBC \>= 3,000/mm\^3
  • +59 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

tanespimycin

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

Study Officials

  • Paul Chapman

    Memorial Sloan Kettering 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

July 8, 2004

First Posted

July 12, 2004

Study Start

June 1, 2004

Primary Completion

February 1, 2007

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

US(1)