Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019331
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2004-04
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 made from a peptide may make the body build an immune response to kill tumor cells Combining vaccine therapy with interleukin-2 andor sargramostim may be a more effective treatment for solid tumors
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 andor sargramostim in treating adults who have metastatic solid tumors
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 andor sargramostim in treating adults who have metastatic solid tumors
Detailed Description:
OBJECTIVES
Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients
Determine whether vaccination with synthetic peptides corresponding to the tumors ras mutation with DetoxPC adjuvant interleukin-2 IL-2 andor sargramostim GM-CSF can induce or boost a patients cellular immunity to that particular mutation
Determine the type and characteristics of the cellular immune response generated
Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 andor GM-CSF
Correlate immune response with tumor response in patients treated with these regimens
OUTLINE Patients are assigned to one of three treatment groups
Group I closed to accrual 6401 Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously SC once every 5 weeks for 3 courses Beginning 4 days after vaccination patients receive interleukin-2 IL-2 SC 5 days a week for 2 weeks
Group II closed to accrual 6401 Patients receive sargramostim GM-CSF SC daily beginning 1 day prior to the vaccination and continuing for 4 days Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2 Patients are vaccinated once every 4 weeks for 3 courses
Group III Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II
In all groups patients receive up to 15 vaccinations in the absence of disease progression
Patients are followed every 2 months
PROJECTED ACCRUAL A maximum of 60 patients 20 per treatment group will be accrued for this study within 2-4 years
Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients
Determine whether vaccination with synthetic peptides corresponding to the tumors ras mutation with DetoxPC adjuvant interleukin-2 IL-2 andor sargramostim GM-CSF can induce or boost a patients cellular immunity to that particular mutation
Determine the type and characteristics of the cellular immune response generated
Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 andor GM-CSF
Correlate immune response with tumor response in patients treated with these regimens
OUTLINE Patients are assigned to one of three treatment groups
Group I closed to accrual 6401 Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously SC once every 5 weeks for 3 courses Beginning 4 days after vaccination patients receive interleukin-2 IL-2 SC 5 days a week for 2 weeks
Group II closed to accrual 6401 Patients receive sargramostim GM-CSF SC daily beginning 1 day prior to the vaccination and continuing for 4 days Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2 Patients are vaccinated once every 4 weeks for 3 courses
Group III Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II
In all groups patients receive up to 15 vaccinations in the absence of disease progression
Patients are followed every 2 months
PROJECTED ACCRUAL A maximum of 60 patients 20 per treatment group will be accrued for this study within 2-4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T96-0078 | None | None | None |
| NCI-97-C-0141F | None | None | None |