Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

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

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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed diagnosis of one the following:
  -  Stage II-IV gastric cancer
  -  Stage IIC-IV ovarian cancer in first complete remission
  -  CA 125 normal and stable*
  -  Grade III anaplastic astrocytoma
  -  Stage IV (M1) prostate adenocarcinoma
  -  No small cell variations
  -  No biochemical progression after definitive surgery, defined by the following:
  -  Prostate-specific antigen more than 0.4 ng/mL which remains elevated on 2 additional measurements at least 2 weeks apart after prostatectomy
  -  Three consecutive rises in PSA, each at least 1 month apart after definitive radiotherapy
  -  Must be receiving androgen blockade
  -  PSA less than 5 ng/mL and stable*
  -  Documented EGFRvIII expression in primary tumor
  -  Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: *Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days
  PATIENT CHARACTERISTICS:
  Age:
  -  80 and under
  Performance status:
  -  Zubrod 0
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 10 g/dL
  Hepatic:
  -  SGOT no greater than 2.5 times upper limit of normal (ULN)
  -  Alkaline phosphatase no greater than 2.5 times ULN
  -  No hepatitis
  Renal:
  -  Not specified
  Other:
  -  No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  -  No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products
  -  No autoimmune disease
  -  HIV negative
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 1 month since prior cytotoxic chemotherapy
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  See Disease Characteristics
  -  At least 1 month since prior treatment dose corticosteroids
  -  No concurrent corticosteroids
  Radiotherapy:
  -  See Disease Characteristics
  -  No concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Recovered from all prior therapies
  -  No concurrent enrollment on other phase I studies
  -  No other concurrent immune modulators

Relevance to patient case: possibly relevant