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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00064129 |
Purpose
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 |
Biological: ipilimumab Biological: sargramostim Other: immunoenzyme technique Other: pharmacological study |
Phase I |
| 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: | 36 |
| Study Start Date: | May 2003 |
| Estimated Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 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 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.
Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies. Samples are analyzed for human anti-human antibodies, IgG antibodies to MDX-010 via semi-quantitative ELISA assay, and plasma concentrations of MDX-CTL4A via quantitative ELISA assay.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 6-7 months.
Eligibility| 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
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000309054, UCSF-02558, NCI-6032 |
| Study First Received: | July 8, 2003 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00064129 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage IV prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |