Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019916
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV Recurrent or Progressive Breast or Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Interleukin-2 may stimulate a persons white blood cells to kill tumor cells It is not yet known whether combining vaccine therapy with interleukin-2 is effective in treating breast and ovarian cancer
PURPOSE This randomized phase III trial is studying the side effects of vaccine therapy and interleukin-2 and to see how well they work in treating women with stage IV recurrent or progressive breast or ovarian cancer
PURPOSE This randomized phase III trial is studying the side effects of vaccine therapy and interleukin-2 and to see how well they work in treating women with stage IV recurrent or progressive breast or ovarian cancer
Detailed Description:
OBJECTIVES
Determine whether endogenous cellular immunity to the p53 peptide vaccine is present in patients with stage IV recurrent or progressive breast or ovarian cancer and whether vaccination with these peptides and low-dose interleukin-2 can induce or boost the cellular immunity in these patients
Determine the type and characteristics of cellular immunity generated by this regimen in these patients
Determine the toxicity of this regimen in these patients
Correlate any immunologic response with any objective tumor response to this regimen in these patients
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
All patients undergo apheresis of autologous peripheral blood mononuclear cells which are harvested and selected for monocytes on day -6 The monocyte fraction is cultured with sargramostim GM-CSF and interleukin-4 for 7 days and then pulsed with p53 peptide vaccine
Arm I Patients receive p53 peptide vaccine subcutaneously SC on day 1
Arm II Patients receive p53 peptide vaccine IV over 5 minutes on day 1 Treatment in both arms repeats every 3 weeks for a total of 4 vaccinations 4 courses During courses 3 and 4 patients also receive low-dose interleukin-2 IL-2 SC daily on days 3-7 and days 10-14 Patients with stable or responding disease may continue to receive vaccine and IL-2 treatment for up to 2 years
Patients are followed at 1 month and then every 2-4 months for 2 years
PROJECTED ACCRUAL A maximum of 34 patients will be accrued for this study within 2 years
Determine whether endogenous cellular immunity to the p53 peptide vaccine is present in patients with stage IV recurrent or progressive breast or ovarian cancer and whether vaccination with these peptides and low-dose interleukin-2 can induce or boost the cellular immunity in these patients
Determine the type and characteristics of cellular immunity generated by this regimen in these patients
Determine the toxicity of this regimen in these patients
Correlate any immunologic response with any objective tumor response to this regimen in these patients
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
All patients undergo apheresis of autologous peripheral blood mononuclear cells which are harvested and selected for monocytes on day -6 The monocyte fraction is cultured with sargramostim GM-CSF and interleukin-4 for 7 days and then pulsed with p53 peptide vaccine
Arm I Patients receive p53 peptide vaccine subcutaneously SC on day 1
Arm II Patients receive p53 peptide vaccine IV over 5 minutes on day 1 Treatment in both arms repeats every 3 weeks for a total of 4 vaccinations 4 courses During courses 3 and 4 patients also receive low-dose interleukin-2 IL-2 SC daily on days 3-7 and days 10-14 Patients with stable or responding disease may continue to receive vaccine and IL-2 treatment for up to 2 years
Patients are followed at 1 month and then every 2-4 months for 2 years
PROJECTED ACCRUAL A maximum of 34 patients will be accrued for this study within 2 years
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-T99-0075 | None | None | None |
| NCI-99-C-0138 | None | None | None |
| NCI-NMOB-9902 | None | None | None |