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Study of Talabostat and Cisplatin in Advanced Melanoma

Sponsor
Point Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00083252
Collaborator
(none)
13
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas Medical Sciences Little Rock Arkansas United States 72205
    2 Cancer Institute Medical Group, Inc. Santa Monica California United States 90404
    3 University of Colorado Health Sciences Center Aurora Colorado United States 80045
    4 Cancer Center of Florida Ocoee Florida United States 34761
    5 Indiana Hematology Oncology Consultants Indianapolis Indiana United States 46202
    6 New Mexico Cancer Center Alliance Albuquerque New Mexico United States 87106
    7 NYU School of Medicine New York New York United States 10016
    8 Fifth Avenue Medical Healthcare New York New York United States 10128
    9 Carolinas Medical Center Charlotte North Carolina United States 28203
    10 Cancer Center of the Carolinas Greenville South Carolina United States 29615
    11 Mary Crowley Medical Research Center Dallas Texas United States 75246
    12 Tyler Cancer Center Tyler Texas United States 75702
    13 Cancer Care Northwest Research Spokane Washington United States 99218

    Sponsors and Collaborators

    • Point Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00083252
    Other Study ID Numbers:
    • PTH-303
    First Posted:
    May 18, 2004
    Last Update Posted:
    Jun 8, 2007
    Last Verified:
    Jun 1, 2007
    Additional relevant MeSH terms:
    Melanoma
    Skin Neoplasms
    Cisplatin

    Study Results

    No Results Posted as of Jun 8, 2007