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Comparison Study of MDX-010 (CTLA-4) Alone and Combined with DTIC in the Treatment of Metastatic Melanoma



Comparison Study of MDX-010 (CTLA-4) Alone and Combined with DTIC in the Treatment of Metastatic Melanoma

For Condition: Melanoma
Status: Completed
Sponsor(s): Medarex ,
Synopsis: The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Clinical diagnosis of unresectable metastatic melanoma. - No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma. Exclusion Criteria Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study: - Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for >=5 years. - Active autoimmune disease. - Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
Total Enrollment: 

Location and Contact Information:

Northern California Melanoma Center
San Francisco,  California,  94109
United States
 

Indiana Oncology/ Hematology Consultants
Indianapolis,  Indiana,  46237
United States
 

Cancer Institute Medical Group
Santa Monica,  California,  90404
United States
 

Joe Arrington Cancer. Research & Treatment Center
Lubbock,  Texas,  79410
United States
 

Pacific Shores Medical Group
Long Beach,  California,  90813
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

USC/Norris Comprehensive Cancer Center
Los Angeles,  California,  90033
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112
United States
 

Piedmont Oncology Specialists
Charlotte,  North Carolina,  28207
United States
 


Additional Information:
Study ID Numbers:
  MDX010-08; 
Study Start Date: October 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050102

Other Melanoma Studies:
1. Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100

2. Vaccination Against Melanoma and Other Cancers

3. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma

4. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer

5. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

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Comparison Study of MDX-010 (CTLA-4) Alone and Combined with DTIC in the Treatment of Metastatic Melanoma

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