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

Learn more about:
Related Clinical Trial
Induction of Cortical Plasticity S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM Comparing Immobilisation Shells in Cranial Radiotherapy FBY PET/CT in Patients With Brain Tumors Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma Longitudinal Metabolomic and Epigenetic Profiling of Bodyfluids From Patients With Lung and Brain Cancer Receiving Radiation Therapy Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients Prevalence of Post-craniotomy Headache in Siriraj Hospital Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma Wise Cortical Strip for Intraoperative Neurophysiological Monitoring Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI) A Study of Cognitive Changes in Patients Receiving Brain Radiation

Brief Title

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

Official Title

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

Brief 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


        -  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 Phase

Phase 1

Study Type


Primary Outcome



Brain Tumors



Study Arms / Comparison Groups

 EGFR vaccine with GMCSF
Description:  EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

June 2001

Completion Date

November 2008

Primary Completion Date

November 2008

Eligibility Criteria


          -  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

                         -  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



          -  80 and under

        Performance status:

          -  Zubrod 0

        Life expectancy:

          -  Not specified


          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL


          -  SGOT no greater than 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase no greater than 2.5 times ULN

          -  No hepatitis


          -  Not specified


          -  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


        Biologic therapy:

          -  Not specified


          -  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


          -  See Disease Characteristics

          -  No concurrent radiotherapy


          -  See Disease Characteristics


          -  Recovered from all prior therapies

          -  No concurrent enrollment on other phase I studies

          -  No other concurrent immune modulators




18 Years - 80 Years

Accepts Healthy Volunteers



Robert B. Montgomery, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Southwest Oncology Group


 National Cancer Institute (NCI)

Study Sponsor

Robert B. Montgomery, MD, Study Chair, VA Puget Sound Health Care System

Verification Date

March 2015