Study of Talabostat and Cisplatin in Advanced Melanoma
1 other identifier
interventional
N/A
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2004
CompletedFirst Posted
Study publicly available on registry
May 18, 2004
CompletedJune 8, 2007
June 1, 2007
May 14, 2004
June 7, 2007
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205, United States
Cancer Institute Medical Group, Inc.
Santa Monica, California, 90404, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Cancer Center of Florida
Ocoee, Florida, 34761, United States
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, 46202, United States
New Mexico Cancer Center Alliance
Albuquerque, New Mexico, 87106, United States
NYU School of Medicine
New York, New York, 10016, United States
Fifth Avenue Medical Healthcare
New York, New York, 10128, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29615, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Cancer Care Northwest Research
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2004
First Posted
May 18, 2004
Last Updated
June 8, 2007
Record last verified: 2007-06