Study of Talabostat and Cisplatin in Advanced Melanoma

Status:

COMPLETED

Study of Talabostat and Cisplatin in Advanced Melanoma

Lead Sponsor:

Point Therapeutics

Conditions:

Melanoma

Skin Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00083252

Last Update

June 8 2007

Active Locations (13)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (13 locations)

University of Arkansas Medical Sciences

Little Rock, Arkansas, United States, 72205

Cancer Institute Medical Group, Inc.

Santa Monica, California, United States, 90404

University of Colorado Health Sciences Center

Aurora, Colorado, United States, 80045