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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023634
Recruitment Status : Terminated (lack of accrual)
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Brain Tumors Gastric Cancer Ovarian Cancer Prostate Cancer Biological: KLH Biological: GMCSF Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Start Date : June 2001
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Experimental: EGFR vaccine with GMCSF
EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
Biological: GMCSF
arm 1: 100 mcg w/EGFRvIII
Other Name: sargramostim

Experimental: EGFR vaccine with KLH
EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
Biological: KLH
100 mcg w/EGFRvIII
Other Name: keyhole limpet

Primary Outcome Measures :
  1. toxicity [ Time Frame: during treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023634

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United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
United States, Washington
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Robert B. Montgomery, MD VA Puget Sound Health Care System

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Responsible Party: Southwest Oncology Group Identifier: NCT00023634     History of Changes
Other Study ID Numbers: S0114
U10CA032102 ( U.S. NIH Grant/Contract )
R01CA082661 ( U.S. NIH Grant/Contract )
S0114 ( Other Identifier: SWOG )
UW-106 ( Other Identifier: University of Washington )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Southwest Oncology Group:
stage II gastric cancer
stage III gastric cancer
stage IV 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

Additional relevant MeSH terms:
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Prostatic Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Stomach Neoplasms
Brain Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases