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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Tumors, Gastric Cancer, Ovarian Cancer, Prostate Cancer

Intervention / Treatment
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* Biological: KLH
* Biological: GMCSF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR vaccine with GMCSF<br>EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m | Biological: GMCSF<br>* arm 1: 100 mcg w/EGFRvIII<br>* Other names: sargramostim;|
| Experimental: EGFR vaccine with KLH<br>EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m | Biological: KLH<br>* 100 mcg w/EGFRvIII<br>* Other names: keyhole limpet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | during treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV gastric cancer, stage II gastric cancer, stage III gastric cancer, recurrent gastric cancer, adenocarcinoma of the prostate, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent adult brain tumor, stage IV prostate cancer, recurrent prostate cancer, adult anaplastic astrocytoma