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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
Both
Brain Tumors, Gastric Cancer, Ovarian Cancer, Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

toxicity

Outcome Time Frame:

during treatment

Safety Issue:

Yes

Principal Investigator

Robert B. Montgomery, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Veterans Affairs

Authority:

United States: Federal Government

Study ID:

CDR0000068824

NCT ID:

NCT00023634

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

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Wenatchee Valley Clinic Wenatchee, Washington  98801
Bay Regional Medical Center Bay City, Michigan  48708
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060