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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

NCTNCT00170157 (opens ClinicalTrials.gov in a new tab)Other idMC0253Other idNCI-2009-01214Other idMC0253Other idP30CA015083

Overview

Status
Completed
Phase
Phase 2
Enrollment
112 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2004
Primary completion
Apr 2011
Completion
Jun 2013
First posted
15 Sept 2005 (estimated)
Last update posted
15 May 2017
Conditions
Prostate Adenocarcinoma · Prostate Carcinoma · Recurrent Prostate Carcinoma · Stage III Prostate Cancer · Stage IV Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420062008201020122014
  1. Ph 2

    Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

    NCT00170157

    Jun 2004 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BicalutamideDrug
  • FlutamideDrug
  • Goserelin AcetateDrug
  • IpilimumabDrug
  • Leuprolide AcetateDrug
  • Pharmacological StudyOther

Arms2

  • Experimental

    Arm I

    Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy \<= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy \<= 21 days prior to enrollment) of AA therapy.

  • Active comparator

    Arm II

    Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Progression-free at 18 Months

    Time frame · 18 months from the start of AA therapy

    Registry description

    PSA progression is defined as a rise in PSA to \>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.

Secondary outcomes(1)
  1. Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response

    Time frame · 3 months

    Registry description

    Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 18 months from the start of AA therapy

Number of Participants Progression-free at 18 Months

GroupValue (participants)
Entire Study Population0
Secondary and other outcome results(1)
Secondary outcomeNumber· 3 months

Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response

GroupValue (percentage of participants)
Androgen Ablative (AA) Therapy + MDX-01055
Androgen Ablative (AA) Then AA Therapy + MDX-01039

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Entire Study PopulationAll participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.–10 / 110107 / 110

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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