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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098449 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may make the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in patients with progressive or locally recurrent prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: fowlpox-PSA-TRICOM vaccine Biological: recombinant fowlpox GM-CSF vaccine adjuvant Biological: vaccinia-PSA-TRICOM vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer and Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2004 |
| Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of booster vaccinations comprising vaccinia-PSA-TRICOM (rV-PSA-TRICOM) with or without recombinant fowlpox-GM-CSF (rF-GM-CSF). Patients are assigned to 1 of 5 groups.
Cohorts of 3-6 patients in each group receive escalating doses of booster vaccinations comprising rF-PSA-TRICOM with or without rF-GM-CSF 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.
Treatment in all groups continues in the absence of unacceptable toxicity or disease progression.
Patients are followed annually for up to 15 years.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 30 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* adenocarcinoma of the prostate, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Neurologic
Gastrointestinal
Immunologic
No active autoimmune disease, including any of the following:
No other altered immune function, including any of the following conditions:
Other
Able to avoid close household contact with any of the following for at least 3 weeks after each study vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
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: | CDR0000401519, NCI-05-C-0017, NCI-6066 |
| Study First Received: | December 7, 2004 |
| Last Updated: | July 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098449 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer adenocarcinoma of the prostate |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |