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

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

This study has been completed.

Sponsored by:	Medarex
Information provided by:	Medarex
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

MedlinePlus related topics:

Melanoma

Drug Information available for:

Ipilimumab Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

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.

Further study details as provided by Medarex:

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

Medarex

More Information

Study ID Numbers:	MDX010-08
First Received:	November 21, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00050102
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Cytotoxic T-lymphocyte antigen 4

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2008