Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003556
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase Ib Trial of Intratumoral Injection of a Recombinant Canarypox Virus Encoding Human B71 ALVAC-hB71 or a Combination of ALVAC-hB71 and a Recombinant Canarypox Virus Encoding Human Interleukin 12 ALVAC-hIL-12 in Patients With Surgically Incurable Melanoma
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery Vaccines may make the body build an immune response that may kill tumor cells Combining more than one vaccine may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the toxic effects associated with ALVAC-hB71 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma
II Characterize the inflammatory and lymphokine response to this regimen in these patients
III Examine the extent of nodule regression humoral immune response and cytolytic T cell activity with this regimen in these patients
OUTLINE This is a dose escalation study of ALVAC-hB71
Patients receive ALVAC-hB71 alone or combined with ALVAC-hIL-12 intratumorally on days 1 4 8 and 11 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB71 The maximum tolerated dose is defined as the dose of ALVAC-hB71 at which no more than 1 of 5 patients experiences dose limiting toxicity
Patients are followed at 1 2 4 8 11 15 22 and 43 days after the first vaccination
I Determine the toxic effects associated with ALVAC-hB71 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma
II Characterize the inflammatory and lymphokine response to this regimen in these patients
III Examine the extent of nodule regression humoral immune response and cytolytic T cell activity with this regimen in these patients
OUTLINE This is a dose escalation study of ALVAC-hB71
Patients receive ALVAC-hB71 alone or combined with ALVAC-hIL-12 intratumorally on days 1 4 8 and 11 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB71 The maximum tolerated dose is defined as the dose of ALVAC-hB71 at which no more than 1 of 5 patients experiences dose limiting toxicity
Patients are followed at 1 2 4 8 11 15 22 and 43 days after the first vaccination
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 |
|---|---|---|---|
| CDR0000066619 | REGISTRY | PDQ Physician Data Query | None |
| UAB-9705 | None | None | None |
| NCI-T97-0046 | None | None | None |