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Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
This study is ongoing, but not recruiting participants.
First Received: September 13, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023634
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Gastric Cancer
Ovarian Cancer
Prostate Cancer
Biological: EGFR antisense DNA
Biological: keyhole limpet hemocyanin
Biological: sargramostim
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: June 2001
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

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023634

Locations
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
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
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
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Robert B. Montgomery, MD Veterans Affairs Medical Center - Seattle
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068824, SWOG-S0114, UW-106, NCI-V01-1664
Study First Received: September 13, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00023634     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Gonadal Disorders
Urogenital Neoplasms
Central Nervous System Neoplasms
Ovarian Diseases
Keyhole-limpet hemocyanin
Genital Diseases, Female
Stomach Diseases
Stomach Neoplasms
Ovarian Cancer
Nervous System Neoplasms
Endocrine Gland Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Astrocytoma
Adjuvants, Immunologic
Genital Neoplasms, Female
Endocrine System Diseases
Ovarian Epithelial Cancer
Genital Diseases, Male
Recurrence
Brain Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Stomach Cancer
Adenocarcinoma

Additional relevant MeSH terms:
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Gonadal Disorders
Physiological Effects of Drugs
Urogenital Neoplasms
Central Nervous System Neoplasms
Ovarian Diseases
Keyhole-limpet hemocyanin
Genital Diseases, Female
Stomach Diseases
Neoplasms by Site
Stomach Neoplasms
Nervous System Neoplasms
Endocrine Gland Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Nervous System Diseases
Adjuvants, Immunologic
Genital Neoplasms, Female
Endocrine System Diseases
Genital Diseases, Male
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009