Clinical trial NCT00170157
Conditions: Prostate Adenocarcinoma Prostate Carcinoma Recurrent Prostate Carcinoma Stage III Prostate Cancer Stage IV Prostate Cancer
Sponsor: Mayo Clinic
Start date: 2004-06-01; Completion date: 2013-06-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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 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.

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. To specifically examine whether concomitant AA therapy + MDX-010 can be used to prolong the progression-free interval in advanced prostate cancer patients compared with inductive short-term AA therapy alone.

III. To specifically examine whether concomitant AA therapy + MDX-010 can be used to enhance initial PSA responses in advanced prostate cancer patients compared with inductive short-term AA therapy alone.

IV. To specifically examine whether delayed MDX-010 can be used to induce PSA response in patients experiencing disease progression following cessation of short-term AA therapy.

V. To generally examine whether MDX-010 enhances host immune response that might be involved in conferring treatment advantages to patients receiving AA therapy.

VI. To specifically examine whether MDX-010 potentiates T-cell responses in advanced prostate cancer patients initiating inductive short-term AA therapy.

VII. To further examine whether treatment induced T-cell responses correlate with clinical response to treatment.

VIII. To examine whether short-term AA there (+/- MDX-010) induces the appearance of newly emigrated T or immature and/or B cells.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

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.

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

After completion of study treatment, patients are followed periodically.

Arms: arm 1: 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. arm 2: Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.
Interventions: intervention 1: Bicalutamide intervention 2: Flutamide intervention 3: Goserelin Acetate intervention 4: Ipilimumab intervention 5: Leuprolide Acetate intervention 6: Pharmacological Study
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given SC intervention 4: Given IV intervention 5: Given IM intervention 6: Correlative study

Protocol documents: