Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019006
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Vaccine Therapy in Treating Patients With Colon Pancreatic or Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Pilot Study of Vaccine Therapy With Tumor-Specific Mutated Ras Peptides in the Adjuvant Setting in Patients With Colorectal Pancreatic or Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
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 mutated ras peptides may make the body build an immune response to and kill tumor cells
PURPOSE Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon pancreatic or lung cancer
PURPOSE Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon pancreatic or lung cancer
Detailed Description:
OBJECTIVES I Determine whether endogenous cellular or humoral immunity to a tumor-specific mutated ras protein is present in patients with colorectal pancreatic or lung cancer
II Determine whether vaccination with a synthetic peptide corresponding to the tumors ras mutation combined with Detox-B adjuvant can induce or boost cellular immunity to that particular mutation in this patient population
III Determine the type and characteristics of any cellular immunity generated in these patients treated with this regimen
IV Determine the tolerance and toxicity spectra of such peptides given with Detox-B adjuvant in these patients
V Determine the immune response associated with each peptide dose in these patients
VI Assess any tumor response that may occur with treatment in these patients treated with this regimen
PROTOCOL OUTLINE This is a dose-escalation study Patients receive tumor-specific mutated ras peptide combined with Detox-B adjuvant subcutaneously monthly for 3 months Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease or with a specific immunologic response may receive 3 additional monthly vaccinations
Cohorts of 3-6 patients receive escalating doses of tumor-specific mutated ras peptide combined with Detox-B adjuvant until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL
A total of 33 patients 12 in the adjuvant setting will be accrued for this study within 12 months
II Determine whether vaccination with a synthetic peptide corresponding to the tumors ras mutation combined with Detox-B adjuvant can induce or boost cellular immunity to that particular mutation in this patient population
III Determine the type and characteristics of any cellular immunity generated in these patients treated with this regimen
IV Determine the tolerance and toxicity spectra of such peptides given with Detox-B adjuvant in these patients
V Determine the immune response associated with each peptide dose in these patients
VI Assess any tumor response that may occur with treatment in these patients treated with this regimen
PROTOCOL OUTLINE This is a dose-escalation study Patients receive tumor-specific mutated ras peptide combined with Detox-B adjuvant subcutaneously monthly for 3 months Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease or with a specific immunologic response may receive 3 additional monthly vaccinations
Cohorts of 3-6 patients receive escalating doses of tumor-specific mutated ras peptide combined with Detox-B adjuvant until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL
A total of 33 patients 12 in the adjuvant setting will be accrued for this study within 12 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-T93-0152N | None | None | None |
| NCI-94-C-0096D | None | None | None |