MDX-010 for Advanced Prostate Cancer - Full Text View

Sponsors and Collaborators:	Mayo Clinic Department of Defense U.S. Army Medical Research Acquisition Activity Medarex
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00170157

Purpose

A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Combination Androgen Ablative Therapy	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Ipilimumab Leuprolide acetate Leuprolide Bicalutamide Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Primary endpoint will be the proportion of patients remaining progression-free [ Time Frame: 18 months from the time patient receives the MDX-010. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Monitor the initial PSA response which encompasses absolute nadir value, time-until-nadir, and greatest percent decline in PSA (at nadir) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	June 2005
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3 months of concurrent AA therapy + MDX-010	Drug: Combination Androgen Ablative Therapy Lupron 7.5mg monthly times 3 months Casodex 50mg daily times 3 months MDX-010 3mg/kg one time dose
2: Active Comparator 3 months of initial AA therapy alone	Drug: Combination Androgen Ablative Therapy Lupron 7.5mg monthly times 3 months Casodex 50mg daily times 3 months MDX-010 3mg/kg one time dose

Eligibility

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

Criteria

Males 18 years of age or older with histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, any T stage, with or without metastases, with an initial PSA of ≥4.0 ng/ml may be eligible for enrollment into this protocol. Participants may not have underwent prior systemic chemotherapy or prior radiation therapy to the prostate. Includes post radical prostatectomy patients with a rising PSA and patients who have started hormone therapy ≤21 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170157

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Toni Kay Mangskau 507-538-7623
Principal Investigator: Eugene D Kwon, M.D.

Sponsors and Collaborators

Mayo Clinic

Department of Defense

U.S. Army Medical Research Acquisition Activity

Medarex

Investigators

Principal Investigator:

Eugene D. Kwon, M.D.

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( Eugene Dai Kwon, M.D. )
Study ID Numbers:	1564-02, DAMD17-02-1-0245
Study First Received:	September 13, 2005
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00170157
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Cytotoxic T-lymphocyte antigen 4

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009