Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002817
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIAGM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Vaccines may make the body build an immune response to kill melanoma cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients with metastatic melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES I Determine the toxicity of intralesional immunotherapy with a recombinant vaccinia virus encoding the gene for sargramostim GM-CSF in patients with metastatic melanoma II Determine the efficiency of viral infection and GM-CSF gene insertion and function in these patients III Determine the capacity of this regimen to generate antiviral and antitumor immunity in these patients IV Determine the frequency of regression of injected and uninjected lesions in these patients
OUTLINE This is a dose-escalation study of intralesional recombinant vaccinia virus encoding the gene for sargramostim GM-CSF rV-GM-CSF Patients are stratified by center Patients receive small pox vaccinia vaccine via multipuncture technique on day 0 On day 4 patients with a progressive major reaction to the initial vaccination receive rV-GM-CSF intralesionally twice weekly for 5 weeks Only 1 lesion is treated and at least 1 measurable lesion is left untreated in each patient Patients with responding disease after week 5 are retreated at a clinically appropriate dose and schedule Cohorts of 5 patients receive escalating doses of intralesional rV-GM-CSF until the maximum tolerated dose MTD is determined Additional patients receive rV-GM-CSF at the MTD
PROJECTED ACCRUAL Approximately 30 patients 15 for each phase will be accrued for this study
OUTLINE This is a dose-escalation study of intralesional recombinant vaccinia virus encoding the gene for sargramostim GM-CSF rV-GM-CSF Patients are stratified by center Patients receive small pox vaccinia vaccine via multipuncture technique on day 0 On day 4 patients with a progressive major reaction to the initial vaccination receive rV-GM-CSF intralesionally twice weekly for 5 weeks Only 1 lesion is treated and at least 1 measurable lesion is left untreated in each patient Patients with responding disease after week 5 are retreated at a clinically appropriate dose and schedule Cohorts of 5 patients receive escalating doses of intralesional rV-GM-CSF until the maximum tolerated dose MTD is determined Additional patients receive rV-GM-CSF at the MTD
PROJECTED ACCRUAL Approximately 30 patients 15 for each phase will be accrued for this study
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 |
|---|---|---|---|
| NCI-H96-0965 | None | None | None |
| JMC-94-0843 | None | None | None |