Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096551
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-07-07
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-07-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 sc route of administration especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given sc 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 15 mgdl AST and ALT 25 times upper limit of normal
Design
Dose escalation Phase I design Each cohort will consist of 3-6 patients with cohorts 4 5 restricted to include only HLA-A2 patients maximum accrual is 30
Patients in all cohorts receive initial priming with rV- PSAL155TRICOM and rF-GM-CSF sc
The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSAL155TRICOM
Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSAL155TRICOM
Last 5th cohort u
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 sc route of administration especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given sc 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 15 mgdl AST and ALT 25 times upper limit of normal
Design
Dose escalation Phase I design Each cohort will consist of 3-6 patients with cohorts 4 5 restricted to include only HLA-A2 patients maximum accrual is 30
Patients in all cohorts receive initial priming with rV- PSAL155TRICOM and rF-GM-CSF sc
The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSAL155TRICOM
Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSAL155TRICOM
Last 5th cohort u
Detailed Description:
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 sc route of administration especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given sc 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 less than 15 mgdl AST and ALT less than 25 times upper limit of normal
Design
Dose escalation Phase I design Each cohort will consist of 3-6 patients maximum accrual is 30
Patients in all cohorts receive initial priming with rV- PSAL155TRICOM and rF-GM-CSF sc
The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSAL155TRICOM
Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSAL155TRICOM
Last 5th cohort utilizes booster intraprostatic vaccine rF-PSAL155TRICOM and rF-GM-CSF with simultaneous identical booster vaccine given sc
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 sc route of administration especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given sc 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 less than 15 mgdl AST and ALT less than 25 times upper limit of normal
Design
Dose escalation Phase I design Each cohort will consist of 3-6 patients maximum accrual is 30
Patients in all cohorts receive initial priming with rV- PSAL155TRICOM and rF-GM-CSF sc
The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSAL155TRICOM
Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSAL155TRICOM
Last 5th cohort utilizes booster intraprostatic vaccine rF-PSAL155TRICOM and rF-GM-CSF with simultaneous identical booster vaccine given sc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-0017 | None | None | None |