Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer

Completed · Phase 1

Conditions studied: Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7

In brief

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 facts

Study ID

NCT00064129

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2003-05-13

Expected to finish

2012-10-01

Last updated by the study team

2020-07-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed prostate cancer
• Metastatic disease
• Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria:
• Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions
• Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart*
• At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide)
• Testosterone no greater than 50 ng/dL
• Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy
• No history or radiologic evidence of CNS metastases
• Performance status - ECOG 0-2
• At least 12 weeks
• Absolute neutrophil count greater than 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 8 g/dL
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No significant cardiovascular disease
• No New York Heart Association class III or IV congestive heart failure
• No active angina pectoris
• No myocardial infarction within the past 6 months
• Not pregnant or nursing
• Fertile patients must use effective contraception prior to, during, and for 3 months after study participation
• No history of autoimmune disease including, but not limited to, any of the following:
• Autoimmune hemolytic anemia

Where it is running

• UCSF Medical Center-Mount Zion — San Francisco, California, United States

Full record on ClinicalTrials.gov

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