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

Melanoma Clinical Trial

Official title:

A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050102
• Other study ID #: MDX010-08
• Secondary ID: CA184-013
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2002
• Last updated: January 20, 2011
• Start date: October 2002
• Est. completion date: February 2004

Study information

• Verified date: January 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• MDX-010 (CTLA-4)

Locations

Country	Name	City	State
United States	Piedmont Oncology Specialists	Charlotte	North Carolina
United States	Indiana Oncology/ Hematology Consultants	Indianapolis	Indiana
United States	Pacific Shores Medical Group	Long Beach	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Joe Arrington Cancer. Research & Treatment Center	Lubbock	Texas
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Northern California Melanoma Center	San Francisco	California
United States	Cancer Institute Medical Group	Santa Monica	California
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm