Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023634
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2001-09-13
Brief Title:
S0114 Vaccine Therapy in Treating Patients With Gastric Prostate or Ovarian Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
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:
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| R01CA082661 | NIH | None | None |
| S0114 | OTHER | None | None |
| UW-106 | OTHER | University of Washington | httpsreporternihgovquickSearchR01CA082661 |