MDX-010 for Advanced Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170157
• Other study ID #: MC0253
• Secondary ID: 1564-02MC0253
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 20, 2013
• Start date: June 2005
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This trial has been designed to ensure the capture of both treatment mechanism-specific data as well as clinically meaningful data within a relatively compressed study interval. Thus, this trial is constructed around a single inductive short-term cycle of AA therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, stage with or without metastatic disease, with the exclusion of central nervous system metastases; includes post radical prostatectomy patients with a rising PSA.

• An initial PSA greater than 4.0 using the Hybritech Assay. For those participants who have received hormone therapy less than or equal to 21 days, a documented PSA of greater than or equal to 4.0 prior to initiation of hormone therapy is acceptable. For those participants who are post radical prostatectomy, a rising PSA is acceptable.

• Adequate organ function defined as: WBC greater than 3,000; platelets greater than 75,000; total bilirubin less than 1.5mg; transaminases less than 2.5 times upper limit of normal; serum creatinine less than 2.0 mg or calculated creatinine clearance greater than 60 mL. All values must be obtained 14 days prior to study entry.

• ECOG performance status of 0 2.

• Patients must be 18 years of age at the time of study entry and able to understand and sign informed consent.

Exclusion Criteria:

• Underlying other serious medical condition which, in the opinion of the investigator, precludes study participation. This includes immuno-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis or lupus.

• Patients not recovered from major infections and/or surgical procedures.

• Prior hormonal therapy greater than 21 days prior to enrollment, including estrogens, LH/RH agonists, antiandrogens, or 5-reductase inhibitors.

• Recent less than 3 months of informed consent usage of immuno suppressive medications including steroids, Immuran, Cyclosporin. Topical or inhalational steroid use is permissible.

• For participants who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study.

• Prior systemic chemotherapy.

• Prior radiation therapy to the prostate

• Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer.

• Prior malignancy, unless the patient has been cancer free for five years or more.

• Uncontrolled underlying medical or psychiatric illness, or serious active infections.

• Patient unwilling to complete all required follow-up visits.

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Combination Androgen Ablative Therapy
Lupron 7.5 mg monthly times 3 months (leuprolide acetate) Casodex 50 mg daily times 3 months (Bicalutamide)

Biological:
• MDX-010 therapy
MDX-010 3 mg/kg one time dose (Ipilimumab)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Medarex, U.S. Army Medical Research Acquisition Activity, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Progression-free at 18 Months	PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart.	18 months from the start of AA therapy	No
Secondary	Number of Participants With an Initial Prostate-specific Antigen (PSA) Response	Initial PSA response is defined as the response to the initially assigned treatment (prior to crossing over). A response is defined as a decrease in PSA 50% or greater that is confirmed 2 consecutive measurements taken at least 2 weeks apart.	Duration of study (up to 18 months)	No

External Links

•   Mayo Clinic Clinical Trials