Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer (NCT00064129) | Clinical Trial Compass
CompletedPhase 1
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
United States42 participantsStarted 2003-05-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 prio…
What they're measuring
1
MTD of the combination of ipilimumab with GM-CSF that results in < 33% DLT