|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00124670 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as MDX-010 and GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with MDX-010 and GM-CSF may be an effective treatment for prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of MDX-010 when given together with vaccine therapy and GM-CSF in treating patients with metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: fowlpox-PSA-TRICOM vaccine Biological: ipilimumab Biological: sargramostim Biological: vaccinia-PSA-TRICOM vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I Trial of a PSA Based Vaccine and an Anti-CTLA-4 Antibody in Adults With Metastatic Androgen Independent Prostate Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).
Patients receive a priming vaccination with vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4. Patients then receive booster vaccinations with fowlpox-PSA-TRICOM vaccine SC and MDX-010 IV over 90 minutes on days 15, 43, 71, 99, 127, and 155. Patients also receive GM-CSF SC on days 15-18, 43-46, 71-74, 99-102, 127-130, and 155-158. Patients without disease progression after day 155 may continue to receive fowlpox-PSA-TRICOM vaccine and GM-CSF every 28 days 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 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 4 weeks and then annually for 15 years.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 2-3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Immunologic
No autoimmune disease that requires treatment, including any of the following:
No other acute, chronic, or exfoliative skin condition, including any of the following:
Other
Able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccination:
Individuals with other acute, chronic, or exfoliative skin condition, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 2 weeks since prior and no concurrent systemic or topical steroids, including steroid eye drops
No concurrent anticancer systemic glucocorticoids
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | James L. Gulley, MD, PhD, FACP | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000437785, NCI-05-C-0167, NCI-7207 |
| Study First Received: | July 26, 2005 |
| Last Updated: | July 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00124670 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 |