Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005039
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-04-06
Brief Title:
Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate prostate cancer Vaccines made from a persons prostate cancer cells may make the body build an immune response to kill tumor cells
Detailed Description:
OBJECTIVES
I Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen PSA vaccine in patients with advanced adenocarcinoma of the prostate
II Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients
III Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients
IV Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order
OUTLINE This is a randomized open-label multicenter dose-escalation study of recombinant fowlpox prostate-specific antigen PSA vaccine
SAFETY COHORT The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly IM Treatment repeats every 4 weeks for 3 courses In the absence of unacceptable toxicity in the first cohort the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level In the presence of unacceptable toxicity in the first cohort the second cohort of 3 patients receives the same vaccine at a dose level lower than the first cohort dose level The maximum tolerated dose MTD is the dose preceding that at which 1 of 6 patients experiences grade 3 or worse dose-limiting toxicity
Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine
GROUP A no prior recombinant vaccinia-PSA vaccine Patients are randomized to one of two vaccination arms
ARM I Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses
ARM II Patients receive the same vaccines as in arm I but in reverse order
GROUP B prior recombinant vaccinia-PSA vaccine Patients receive treatment as in arm I group A
GROUPS A AND B Patients with stable or responding disease at 6 months after completion of vaccination therapy may continue treatment on the group and arm to which they were originally assigned Treatment repeats every 6-9 months in the absence of disease progression
Patients are followed monthly for 6 months and then every 3 months thereafter
I Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen PSA vaccine in patients with advanced adenocarcinoma of the prostate
II Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients
III Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients
IV Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order
OUTLINE This is a randomized open-label multicenter dose-escalation study of recombinant fowlpox prostate-specific antigen PSA vaccine
SAFETY COHORT The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly IM Treatment repeats every 4 weeks for 3 courses In the absence of unacceptable toxicity in the first cohort the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level In the presence of unacceptable toxicity in the first cohort the second cohort of 3 patients receives the same vaccine at a dose level lower than the first cohort dose level The maximum tolerated dose MTD is the dose preceding that at which 1 of 6 patients experiences grade 3 or worse dose-limiting toxicity
Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine
GROUP A no prior recombinant vaccinia-PSA vaccine Patients are randomized to one of two vaccination arms
ARM I Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses
ARM II Patients receive the same vaccines as in arm I but in reverse order
GROUP B prior recombinant vaccinia-PSA vaccine Patients receive treatment as in arm I group A
GROUPS A AND B Patients with stable or responding disease at 6 months after completion of vaccination therapy may continue treatment on the group and arm to which they were originally assigned Treatment repeats every 6-9 months in the absence of disease progression
Patients are followed monthly for 6 months and then every 3 months thereafter
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 |
|---|---|---|---|
| CDR0000067630 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062490 |
| DFHCC 98-262 | None | None | None |
| U01CA062490 | NIH | None | None |