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

September 13, 2001
February 6, 2009
June 2001
 
 
 
Complete list of historical versions of study NCT00023634 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

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.

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.

Phase I
Interventional
Treatment, Open Label
  • Brain and Central Nervous System Tumors
  • Gastric Cancer
  • Ovarian Cancer
  • Prostate Cancer
  • Biological: EGFR antisense DNA
  • Biological: keyhole limpet hemocyanin
  • Biological: sargramostim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
24
 
 

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
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023634
 
CDR0000068824, SWOG-S0114, UW-106, NCI-V01-1664
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert B. Montgomery, MD Veterans Affairs Medical Center - Seattle
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP