Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004881
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-03-07
Brief Title:
Vaccine Therapy in Treating Patients With Advanced Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2001-02
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:
RATIONALE Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the safety tolerance and maximum tolerated dose of TG4010 in patients with MUC1 positive advanced cancer II Determine the biological and immunological effects of this regimen in this patient population
OUTLINE This is a dose escalation study Patients receive TG4010 IM weekly for 4 weeks every other week for 8 weeks and then every 4 weeks Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of TG4010 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience treatment related grade 3 toxicity If any patient experiences grade 4 toxicity the prior dose level is considered the MTD
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4 months
OUTLINE This is a dose escalation study Patients receive TG4010 IM weekly for 4 weeks every other week for 8 weeks and then every 4 weeks Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of TG4010 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience treatment related grade 3 toxicity If any patient experiences grade 4 toxicity the prior dose level is considered the MTD
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4 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-G00-1677 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-9909055-01B | None | None | None |
| CDR0000067544 | REGISTRY | None | None |