Study of Talabostat and Cisplatin in Advanced Melanoma

June 7, 2007 updated by: Point Therapeutics
The purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Sciences
    • California
      • Santa Monica, California, United States, 90404
        • Cancer Institute Medical Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
    • Florida
      • Ocoee, Florida, United States, 34761
        • Cancer Center of Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Hematology Oncology Consultants
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Cancer Center Alliance
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine
      • New York, New York, United States, 10128
        • Fifth Avenue Medical Healthcare
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Center Of The Carolinas
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
  • Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
  • ECOG Performance Status of 0, 1, or 2
  • Expected survival ≥12 weeks
  • Written informed consent

Exclusion Criteria:

  • More than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma
  • Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
  • Clinically significant laboratory abnormalities
  • Symptomatic CNS metastases
  • Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
  • The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy
  • Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
  • Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Point Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 17, 2004

First Posted (Estimate)

May 18, 2004

Study Record Updates

Last Update Posted (Estimate)

June 8, 2007

Last Update Submitted That Met QC Criteria

June 7, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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