Ovarian Cancer 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.
Full 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 Criteria
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
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There are 12 Locations for this study
Bay City Michigan, 48708, United States
Port Huron Michigan, 48060, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mt. Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98114, United States
Seattle Washington, 98195, United States
Sedro-Wooley Washington, 98284, United States
Spokane Washington, 99202, United States
Wenatchee Washington, 98801, United States
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