Prostate Cancer Clinical Trial
Official title:
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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