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

Phase 1
18 Years
80 Years
Not Enrolling
Brain Tumors, Gastric Cancer, Ovarian Cancer, Prostate Cancer

Thank you

Trial Information

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


- Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or
keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing

- 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

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

during treatment

Safety Issue:


Principal Investigator

Robert B. Montgomery, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Veterans Affairs


United States: Federal Government

Study ID:




Start Date:

June 2001

Completion Date:

November 2008

Related Keywords:

  • Brain Tumors
  • Gastric Cancer
  • Ovarian Cancer
  • Prostate Cancer
  • 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
  • Brain Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms



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