Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00096551 · ClinicalTrials.gov registry record · Phase 1
A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer With Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00096551: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00096551 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096551, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: * Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer. * Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to: * Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2). * Making the tumor cell more susceptible to killing via upregulation of ICAM. * The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets. * Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response. Objectives: * 1: Safety and feasibility of an intraprostatic vaccine strategy. * 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay. * 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies. Eligibility: * Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT. * Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled. * Hepatic function: Bilirubin \< 1.5 mg/dl, AST and ALT\< 2.5 times upper limit of normal Design: * Dose escalation Phase I design. Each cohort wil
Interventions
- DRUG Recombinant Fowlpox-GM-CSF
- DRUG Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM)
- DRUG Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2004-11-01 |
| Est. Completion | 2011-07-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00096551
The ClinicalTrials.gov registry entry for NCT00096551 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Recombinant Fowlpox-GM-CSF is the first listed.
NCT00096551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00096551 about?
NCT00096551 is a clinical study titled "A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer With Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy". Background: * Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer. * Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especiall...
What is the current status of trial NCT00096551?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-11-01. Estimated completion is 2011-07-25.
What interventions are being tested in trial NCT00096551?
The interventions under investigation include: Recombinant Fowlpox-GM-CSF (DRUG), Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM) (DRUG), Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM) (DRUG).
Who is sponsoring clinical trial NCT00096551?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.