Overview

Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
Male
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
Medarex
National Cancer Institute (NCI)
U.S. Army Medical Research Acquisition Activity
United States Department of Defense
Treatments:
Androgens
Antibodies, Monoclonal
Ascorbic Acid
Bicalutamide
Estrogens, Conjugated (USP)
Flutamide
Goserelin
Ipilimumab
Leuprolide
Methyltestosterone
Criteria
Inclusion Criteria:

- NOTE: All values must be obtained =< 14 prior to study entry

- Histologically confirmed adenocarcinoma of the prostate staged within 180 days of
study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the
exclusion of central nervous system (CNS) metastases; includes post radical
prostatectomy patients with a rising PSA

- An initial PSA >= 4.0 ng/mL (Hybritech Assay)

- For those patients who have received hormone therapy =< 21 days, a documented PSA of
>= 4.0 prior to initiation of hormone therapy is acceptable.

- For patients who are post radical prostatectomy, a rising PSA is acceptable.

- Adequate organ function defined as: WBC >= 3,000/uL; platelets >= 75,000/uL; total
bilirubin =< 1.5 mg/dL; transaminases =< 2.5 x upper limit of normal (ULN); serum
creatine =< 2.0 mg/dL or calculated creatinine clearance >= 60 mL/min

- ECOG performance status of 0-2

- 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 immune-suppressive disease such as AIDS
or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis

- Patients not recovered from major infections and/or surgical procedures

- Prior hormonal therapy > 21 days prior to enrollment, including estrogens, LH/RH
agonists, or antiandrogens

- Recent (=< 3 months of informed consent) usage of immune-suppressive medication
including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is
permissible

- Prior systemic chemotherapy

- Prior radiation therapy to the prostate

- 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

- History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre
Syndrome)

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

- For patients 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

- No other investigational drugs will be allowed during the study

- Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic
therapy may not be used while the patient is on study