Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030693
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2002-02-14
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intra-Lesional rF-B71 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
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 I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors Vaccines may make the body build an immune response to kill tumor cells Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells It is not yet known which vaccine may be more effective in treating metastatic solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I To determine and compare the feasibility and clinical toxicity of administering rF-B71 and rF-TRICOM vaccines to patients with accessible cutaneous subcutaneous or lymph node metastatic tumors
II To determine and compare the feasibility and clinical toxicity of administering rF-B71 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors
III To determine the optimal dose of rF-B71 and rF-TRICOM vaccine delivered by intra-tumoral injection
IV To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B71 vaccine to similar patients receiving rF-TRICOM vaccine
SECONDARY OBJECTIVES
I To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B71 and rF-TRICOM in patients with cutaneous tumors and visceral tumors
II To evaluate the quality of life during vaccine administration
OUTLINE This is a randomized study with dose-escalation component Patients are stratified according to tumor location cutaneous subcutaneous or lymph node metastases vs visceral metastases Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rF-B71 vaccine intratumorally on day 1
ARM II Patients receive fowlpox-TRICOM vaccine intratumorally on day 1
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional courses
Three patients from the cutaneous disease CD stratum are treated at low-dose in each treatment arm If no more than 1 of 6 patients experience dose-limiting toxicity DLT then 6 additional CD patients are randomized to high-dose treatment If no more than 1 of these 6 patients experience DLT then 12 patients from the visceral disease VD stratum are randomized to low-dose treatment If no more than 2 of 12 VD patients experience DLT then the next cohort of 12 VD patients is randomized to high-dose treatment If 3 of the original 12 VD patients experience DLT then 6 additional VD patients receive low-dose treatment If no more than 3 of 18 patients experience DLT then 12 VD patients receive high-dose treatment
Quality of life is assessed at baseline monthly during therapy and then at the end of therapy
Patients are followed every 3 months
I To determine and compare the feasibility and clinical toxicity of administering rF-B71 and rF-TRICOM vaccines to patients with accessible cutaneous subcutaneous or lymph node metastatic tumors
II To determine and compare the feasibility and clinical toxicity of administering rF-B71 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors
III To determine the optimal dose of rF-B71 and rF-TRICOM vaccine delivered by intra-tumoral injection
IV To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B71 vaccine to similar patients receiving rF-TRICOM vaccine
SECONDARY OBJECTIVES
I To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B71 and rF-TRICOM in patients with cutaneous tumors and visceral tumors
II To evaluate the quality of life during vaccine administration
OUTLINE This is a randomized study with dose-escalation component Patients are stratified according to tumor location cutaneous subcutaneous or lymph node metastases vs visceral metastases Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rF-B71 vaccine intratumorally on day 1
ARM II Patients receive fowlpox-TRICOM vaccine intratumorally on day 1
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional courses
Three patients from the cutaneous disease CD stratum are treated at low-dose in each treatment arm If no more than 1 of 6 patients experience dose-limiting toxicity DLT then 6 additional CD patients are randomized to high-dose treatment If no more than 1 of these 6 patients experience DLT then 12 patients from the visceral disease VD stratum are randomized to low-dose treatment If no more than 2 of 12 VD patients experience DLT then the next cohort of 12 VD patients is randomized to high-dose treatment If 3 of the original 12 VD patients experience DLT then 6 additional VD patients receive low-dose treatment If no more than 3 of 18 patients experience DLT then 12 VD patients receive high-dose treatment
Quality of life is assessed at baseline monthly during therapy and then at the end of therapy
Patients are followed every 3 months
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 |
|---|---|---|---|
| CPMC-IRB-14535 | None | None | None |
| CDR0000069189 | REGISTRY | PDQ Physician Data Query | None |