Clinical Trials Directory

Trials / Terminated

TerminatedNCT00023634

S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALKLH100 mcg w/EGFRvIII
BIOLOGICALGMCSFarm 1: 100 mcg w/EGFRvIII

Timeline

Start date
2001-06-01
Primary completion
2008-11-01
Completion
2008-11-01
First posted
2003-01-27
Last updated
2015-03-06

Locations

13 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00023634. Inclusion in this directory is not an endorsement.