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

This study has been terminated.
(lack of accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00023634
First received: September 13, 2001
Last updated: July 20, 2012
Last verified: July 2012
  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 Tumors
Gastric Cancer
Ovarian Cancer
Prostate Cancer
Biological: KLH
Biological: GMCSF
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Southwest Oncology Group:

Primary Outcome Measures:
  • toxicity [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: June 2001
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:   18 Years 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
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
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
Investigators
Study Chair: Robert B. Montgomery, MD Department of Veterans Affairs
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00023634     History of Changes
Other Study ID Numbers: CDR0000068824, U10CA032102, R01CA082661, S0114, UW-106
Study First Received: September 13, 2001
Last Updated: July 20, 2012
Health Authority: United States: Federal Government

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:
Brain Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014