Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	80 and under	NCI	SWOG-S0114 UW-106, NCI-V01-1664, S0114, NCT00023634

Objectives

1. Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.
2. Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
3. Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.

Entry 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]

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

Patient Characteristics:

Age:

• 80 and under

Performance status:

• Zubrod 0

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 24 patients (12 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Robert Montgomery, MD, Protocol chair		Ph: 206-277-6878; 800-329-8387

Registry Information
Official Title		An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients with EGFRvIII Expressing Cancers
Trial Start Date		2001-06-01
Registered in ClinicalTrials.gov		NCT00023634
Date Submitted to PDQ		2001-06-19
Information Last Verified		2006-05-18
NCI Grant/Contract Number		CA82661, CA32102

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