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Home > "S" Clinical Trials Conditions > Study of Talabostat and Cisplatin in Advanced Melanoma  Study of Talabostat and Cisplatin in Advanced Melanoma
Study of Talabostat and Cisplatin in Advanced Melanoma
For Condition: Melanoma,Skin Cancer
Status: Recruiting
Sponsor(s): Point Therapeutics ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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.
Total Enrollment:
Location and Contact Information:
Cancer Care Northwest Research *Recruiting*
Spokane, Washington, 99218
United States
Recruiting
Carolinas Medical Center *Not yet recruiting*
Charlotte, North Carolina, 28203
United States
Not yet recruiting
Mary Crowley Medical Research Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting
Cancer Institute Medical Group, Inc. *Not yet recruiting*
Santa Monica, California, 90404
United States
Not yet recruiting
Cancer Center of the Carolinas *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting
Cancer Center of Florida *Recruiting*
Ocoee, Florida, 34761
United States
Recruiting
Additional Information:
Study ID Numbers: PTH-303;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083252
Other Skin Cancer Studies:
1. Study of Talabostat and Cisplatin in Advanced Melanoma
2. ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
3. Phase II Trial of Allovectin-7® for Metastatic Melanoma
4. SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
5. Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
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Study of Talabostat and Cisplatin in Advanced Melanoma
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