Study of Talabostat and Cisplatin in Advanced Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Cancer Institute Medical Group, Inc.
Santa Monica, United StatesUniversity of Colorado Health Sciences Center
Aurora, United StatesCancer Center of Florida
Ocoee, United States