Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT00023634
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2001-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
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 cancer cells.
PURPOSE: This phase I trial is studying two different vaccines to treat patients who have gastric, prostate, or ovarian cancer.
PURPOSE: This phase I trial is studying two different vaccines to treat patients who have gastric, prostate, or ovarian cancer.
Detailed Description:
OBJECTIVES:
* Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.
* Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
* Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.
OUTLINE: Patients are assigned to one of two treatment arms.
* Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.
* Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.
Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study.
* Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.
* Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
* Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.
OUTLINE: Patients are assigned to one of two treatment arms.
* Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.
* Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.
Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01CA082661 | NIH | None | https://reporter.nih.gov/quic… | View |
| S0114 | OTHER | SWOG | View | |
| UW-106 | OTHER | University of Washington | View |