Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004148
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-12-10
Brief Title:
Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Intra Lesional RV-B71 Vaccine in the Treatment of Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2006-06
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 who have unresectable metastatic melanoma Vaccines may make the body build an immune response to kill tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of the rV-B71 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma
II Determine all clinical toxicities associated with this regimen in this patient population
III Determine the safety of this regimen in this patient population IV Assess evidence of host antimelanoma immune reactivity following this regimen
V Determine the effect of this regimen on T-cell immunity VI Assess the clinical response in this patient population receiving this regimen
VII Evaluate quality of life of these patients during this regimen
OUTLINE This is a dose escalation study
Patients receive rV-B71 intralesionally every 4 weeks for 8 weeks weeks 0 4 and 8 Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities
Quality of life is assessed before treatment every 4 weeks and at end of treatment Patients are followed every 3 months
I Determine the maximum tolerated dose of the rV-B71 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma
II Determine all clinical toxicities associated with this regimen in this patient population
III Determine the safety of this regimen in this patient population IV Assess evidence of host antimelanoma immune reactivity following this regimen
V Determine the effect of this regimen on T-cell immunity VI Assess the clinical response in this patient population receiving this regimen
VII Evaluate quality of life of these patients during this regimen
OUTLINE This is a dose escalation study
Patients receive rV-B71 intralesionally every 4 weeks for 8 weeks weeks 0 4 and 8 Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities
Quality of life is assessed before treatment every 4 weeks and at end of treatment 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 |
|---|---|---|---|
| NCI-T99-0006 | None | None | None |
| AECM-99-101 | None | None | None |