Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00064129
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Cancer AJCC v7

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Sargramostim — BIOLOGICAL
    Given SC

Study Details

This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells.

Key Dates

Start date
May 13, 2003
Status verified
Jul 2020
Primary completion
Jan 10, 2011
Completion
Oct 1, 2012

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (monoclonal antibody, colony-stimulating factors)
    Patients receive ipilimumab IV over 90 minutes on day 1 and sargramostim (GM-CSF) SC on days 1-14. Treatment repeats every 28 days for 4-6 courses. GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies. Samples are analyzed for human anti-human antibodies, IgG antibodies to ipilimumab semi-quantitative ELISA assay, and plasma concentrations of ipilimumab via quantitative ELISA assay.

Primary Outcome Measure

MTD of the combination of ipilimumab with GM-CSF that results in < 33% DLT [ Time Frame: Continuously ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-

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By research site
UCSF Medical Center-Mount Zion· San Francisco, CA

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