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

This study has been completed.

First Received: November 21, 2002 Last Updated: February 3, 2010 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00050102

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: Treatment of metastatic melanoma	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:

October 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050102

Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cancer Institute Medical Group
Santa Monica, California, United States, 90404
Northern California Melanoma Center
San Francisco, California, United States, 94109
United States, Indiana
Indiana Oncology/ Hematology Consultants
Indianapolis, Indiana, United States, 46237
United States, North Carolina
Piedmont Oncology Specialists
Charlotte, North Carolina, United States, 28207
United States, Texas
Joe Arrington Cancer. Research & Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MDX010-08, CA184-013
Study First Received:	November 21, 2002
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00050102 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on February 08, 2010