Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060528
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2003-05-07
Brief Title:
Sequential Vaccinations in Prostate Cancer Patients
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Pilot Study of Sequential Vaccinations With rFowlpox-PSA L155-TRICOM PROSTVAC-FTRICOM Alone or in Combination With rVaccinia-PSA L155-TRICOM PROSTVAC-VTRICOM and the Role of GM-CSF in Men With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
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
Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death
Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer One potential target for a prostate cancer vaccine is prostatic specific antigen PSA due to its restricted expression on prostate cancer and normal prostatic epithelial cells
Objectives
The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor GM-CSF and recombinant fowlpox granulocyte-macrophage colony stimulating factor rF-GM-CSF on the immunologic response in patients treated with these vaccines
Secondary - to determine the change in prostatic specific antigen PSA-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot ELISPOT assay analysis
To document any objective anti-tumor responses that may occur
Eligibility
Patients must have androgen insensitive metastatic prostate cancer
All patients will have received and progressed on hormonal therapy
Must have objective evidence of metastasis or relapsing local disease Therefore must have a rising PSA and at least one of the following positive bone scan palpable disease or positive imaging studies
Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group ECOG status of 0 to 2
Patients must be human leukocyte antigen serotype within HLA-A A serotype group HLA-A2
Granulocyte count greater than or equal to 1500mm3 Platelet greater than or equal to 100000mm3 hemoglobin Hgb greater than or equal to 10GmdL Lymphocyte count greater than or equal to 500mm3 Bilirubin less than 15mgdL aspartate aminotransferase AST and alanine aminotransferase ALT less than 25x upper limit of normal ULNCreatinine Clearance greater than or equal to 60
No significant cardiac disease no significant pulmonary disease no serious inter-current medical illness
Design
Cohorts three four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively
This study will be conducted as a small randomized pilot study to compare the immunologic effects of the above vaccine strategy alone with recombinant granulocyte-macrophage colony stimulating factor GM-CSF or with either of 2 doses of fowlpox-GM-CSF
This study will consist of 4 randomized arms of 8 patients each all of whom are HLA-A2
The maximum accrual to the trial should be 62
Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death
Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer One potential target for a prostate cancer vaccine is prostatic specific antigen PSA due to its restricted expression on prostate cancer and normal prostatic epithelial cells
Objectives
The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor GM-CSF and recombinant fowlpox granulocyte-macrophage colony stimulating factor rF-GM-CSF on the immunologic response in patients treated with these vaccines
Secondary - to determine the change in prostatic specific antigen PSA-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot ELISPOT assay analysis
To document any objective anti-tumor responses that may occur
Eligibility
Patients must have androgen insensitive metastatic prostate cancer
All patients will have received and progressed on hormonal therapy
Must have objective evidence of metastasis or relapsing local disease Therefore must have a rising PSA and at least one of the following positive bone scan palpable disease or positive imaging studies
Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group ECOG status of 0 to 2
Patients must be human leukocyte antigen serotype within HLA-A A serotype group HLA-A2
Granulocyte count greater than or equal to 1500mm3 Platelet greater than or equal to 100000mm3 hemoglobin Hgb greater than or equal to 10GmdL Lymphocyte count greater than or equal to 500mm3 Bilirubin less than 15mgdL aspartate aminotransferase AST and alanine aminotransferase ALT less than 25x upper limit of normal ULNCreatinine Clearance greater than or equal to 60
No significant cardiac disease no significant pulmonary disease no serious inter-current medical illness
Design
Cohorts three four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively
This study will be conducted as a small randomized pilot study to compare the immunologic effects of the above vaccine strategy alone with recombinant granulocyte-macrophage colony stimulating factor GM-CSF or with either of 2 doses of fowlpox-GM-CSF
This study will consist of 4 randomized arms of 8 patients each all of whom are HLA-A2
The maximum accrual to the trial should be 62
Detailed Description:
Background
Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death
Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer One potential target for a prostate cancer vaccine is prostatic specific antigen PSA due to its restricted expression on prostate cancer and normal prostatic epithelial cells
Objectives
The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor GM-CSF and recombinant fowlpox granulocyte-macrophage colony stimulating factor rF-GM-CSF on the immunologic response in patients treated with these vaccines
Secondary - to determine the change in prostatic specific antigen PSA-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot ELISPOT assay analysis
To document any objective anti-tumor responses that may occur
Eligibility
Patients must have androgen insensitive metastatic prostate cancer
All patients will have received and progressed on hormonal therapy
Must have objective evidence of metastasis or relapsing local disease Therefore must have a rising PSA and at least one of the following positive bone scan palpable disease or positive imaging studies
Must have a life expectancy of more than 6 months and the Eastern Cooperative Oncology Group ECOG status of 0 to 2
Patients must be HLA-A2
Granulocyte count greater than or equal to 1500mm3 Platelet greater than or equal to 100000mm3 hemoglobin Hgb greater than or equal to 10GmdL Lymphocyte count greater than or equal to 500mm3 Bilirubin less than 15mgdL aspartate aminotransferase AST and alanine aminotransferase ALT less than 25x upper limit of normal ULNCreatinine Clearance greater than or equal to 60
No significant cardiac disease no significant pulmonary disease no serious inter-current medical illness
Design
Cohorts three four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively
This study will be conducted as a small randomized pilot study to compare the immunologic effects of the above vaccine strategy alone with recombinant GM-CSF or with either of 2 doses of fowlpox-GM-CSF
This study will consist of 4 randomized arms of 8 patients each all of whom are HLA-A2
Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death
Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer One potential target for a prostate cancer vaccine is prostatic specific antigen PSA due to its restricted expression on prostate cancer and normal prostatic epithelial cells
Objectives
The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor GM-CSF and recombinant fowlpox granulocyte-macrophage colony stimulating factor rF-GM-CSF on the immunologic response in patients treated with these vaccines
Secondary - to determine the change in prostatic specific antigen PSA-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot ELISPOT assay analysis
To document any objective anti-tumor responses that may occur
Eligibility
Patients must have androgen insensitive metastatic prostate cancer
All patients will have received and progressed on hormonal therapy
Must have objective evidence of metastasis or relapsing local disease Therefore must have a rising PSA and at least one of the following positive bone scan palpable disease or positive imaging studies
Must have a life expectancy of more than 6 months and the Eastern Cooperative Oncology Group ECOG status of 0 to 2
Patients must be HLA-A2
Granulocyte count greater than or equal to 1500mm3 Platelet greater than or equal to 100000mm3 hemoglobin Hgb greater than or equal to 10GmdL Lymphocyte count greater than or equal to 500mm3 Bilirubin less than 15mgdL aspartate aminotransferase AST and alanine aminotransferase ALT less than 25x upper limit of normal ULNCreatinine Clearance greater than or equal to 60
No significant cardiac disease no significant pulmonary disease no serious inter-current medical illness
Design
Cohorts three four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively
This study will be conducted as a small randomized pilot study to compare the immunologic effects of the above vaccine strategy alone with recombinant GM-CSF or with either of 2 doses of fowlpox-GM-CSF
This study will consist of 4 randomized arms of 8 patients each all of whom are HLA-A2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0176 | None | None | None |