Status:
COMPLETED
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 th...
Detailed Description
OBJECTIVES: I. To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone. II...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00170157
Start Date
June 1 2004
End Date
June 1 2013
Last Update
May 15 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905