Clinical trial NCT00083252: Study of Talabostat and Cisplatin in Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Skin Cancer
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-05-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences
state: Arkansas
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Ocoee
country: United States
facility: Cancer Center of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hematology Oncology Consultants
state: Indiana
city: Albuquerque
country: United States
facility: New Mexico Cancer Center Alliance
state: New Mexico
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Fifth Avenue Medical Healthcare
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest Research
state: Washington
Study officials:
References: