Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019084
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
VACCINE THERAPY WITH TUMOR SPECIFIC MUTATED P53 OR RAS PEPTIDES ALONE OR IN COMBINATION WITH CELLULAR IMMUNOTHERAPY WITH PEPTIDE ACTIVATED LYMPHOCYTES PAL CELLS ALONG WITH SUBCUTANEOUS IL-2
Status:
COMPLETED
Status Verified Date:
2007-04
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 persons white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining vaccine therapy with interleukin-2 may be an effective treatment for advanced cancer
PURPOSE Phase II trial to study the effectiveness of a vaccine made with the patients white blood cells mixed with tumor proteins in treating patients who have advanced cancer
PURPOSE Phase II trial to study the effectiveness of a vaccine made with the patients white blood cells mixed with tumor proteins in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine whether endogenous cellular immunity to a particular tumor-specific mutated p53 or ras protein is present in patients with tumors expressing mutant p53 or ras II Determine whether vaccination with antigen-presenting cells pulsed in vitro with synthetic peptide corresponding to the tumors p53 or ras mutation in the presence of sargramostim GM-CSF can induce or boost patient cellular immunity to the mutated peptide in this patient population III Assess the type and characteristics of the cellular immunity generated IV Determine whether in vivo-primed T-cells generated against the p53 or ras mutation expanded in vitro with corresponding peptide and infused with subcutaneous interleukin-2 can enhance the activity of specific cytotoxic T-lymphocyte immune response andor tumor response in these patients
OUTLINE Patients are assigned to 1 of 2 treatment regimens The first 5 patients accrued are assigned to Regimen A Three weeks after all 5 patients are enrolled additional patients are accrued and assigned to Regimen B All patients undergo peptide hypersensitivity testing with the peptide they will be treated with prior to each vaccination Regimen A Two days prior to each vaccination peripheral blood mononuclear cells PBMC are harvested PBMC are incubated for 48 hours with either patient-specific mutant p53 or ras peptide fragments and sargramostim GM-CSF The antigen-presenting cells APC are irradiated prior to use APC are reinfused on day 0 Treatment repeats after 3 weeks and then every 6 weeks for a total of 4 vaccinations Regimen B Patients are vaccinated with APC as in Regimen A PBMC are harvested prior to the first APC vaccination and 1 week after the second third and fourth APC vaccinations PBMC are incubated for 7 days with either peptide the patient was vaccinated with mutant p53 or ras peptide fragments and interleukin-2 IL-2 The peptide-activated lymphocytes PAL are reinfused over 1 hour 2 weeks after each APC vaccination Patients receive IL-2 subcutaneously 5 days a week for 2 weeks beginning 4 hours after each PAL infusion Patients in both regimens with stable or responding disease continue treatment every 6 weeks Patients achieving complete response continue treatment for up to 1 additional year Patients are followed at 1 and 2 months
PROJECTED ACCRUAL A maximum of 70 patients 5 per Regimen A 28-65 per Regimen B will be accrued for this study
OUTLINE Patients are assigned to 1 of 2 treatment regimens The first 5 patients accrued are assigned to Regimen A Three weeks after all 5 patients are enrolled additional patients are accrued and assigned to Regimen B All patients undergo peptide hypersensitivity testing with the peptide they will be treated with prior to each vaccination Regimen A Two days prior to each vaccination peripheral blood mononuclear cells PBMC are harvested PBMC are incubated for 48 hours with either patient-specific mutant p53 or ras peptide fragments and sargramostim GM-CSF The antigen-presenting cells APC are irradiated prior to use APC are reinfused on day 0 Treatment repeats after 3 weeks and then every 6 weeks for a total of 4 vaccinations Regimen B Patients are vaccinated with APC as in Regimen A PBMC are harvested prior to the first APC vaccination and 1 week after the second third and fourth APC vaccinations PBMC are incubated for 7 days with either peptide the patient was vaccinated with mutant p53 or ras peptide fragments and interleukin-2 IL-2 The peptide-activated lymphocytes PAL are reinfused over 1 hour 2 weeks after each APC vaccination Patients receive IL-2 subcutaneously 5 days a week for 2 weeks beginning 4 hours after each PAL infusion Patients in both regimens with stable or responding disease continue treatment every 6 weeks Patients achieving complete response continue treatment for up to 1 additional year Patients are followed at 1 and 2 months
PROJECTED ACCRUAL A maximum of 70 patients 5 per Regimen A 28-65 per Regimen B 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-T94-0096N | None | None | None |
| NCI-95-C-0105A | None | None | None |