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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064129 |
RATIONALE: 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.
PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody when given with sargramostim in treating patients with metastatic prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: ipilimumab Drug: sargramostim |
Phase I |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor Ipilimumab Cytotoxic T-lymphocyte antigen 4 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (MDX-010) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).
Patients receive MDX-010 IV over 90 minutes on day 1 and sargramostim (GM-CSF) subcutaneously on days 1-14. Treatment repeats every 28 days for a total of 4 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 MDX-010 until the maximum tolerated dose (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.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 6-7 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria:
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*
Testosterone no greater than 50 ng/dL
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No history of autoimmune disease including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No other concurrent hormonal therapy
Radiotherapy
Surgery
Other
United States, California | |||||
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | ||||
San Francisco, California, United States, 94115 | |||||
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
Veterans Affairs Medical Center - San Francisco | Recruiting | ||||
San Francisco, California, United States, 94121 | |||||
Contact: H. Jeffrey Lawrence, MD 415-379-5615 jeffl@medicine.ucsf.edu |
UCSF Helen Diller Family Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000309054, UCSF-02558, NCI-6032 |
First Received: | July 8, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064129 |
Health Authority: | Unspecified |
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