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

SWOG Cancer Research Network

Status and phase: Terminated; Phase 1

Conditions: Gastric Cancer; Brain Tumors; Ovarian Cancer; Prostate Cancer

Treatments: Biological: KLH; Biological: GMCSF

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00023634

UW-106 (Other Identifier)

R01CA082661 (U.S. NIH Grant/Contract)

S0114 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

EGFR vaccine with GMCSF

Experimental group

Description:

EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m

Treatment:

Biological: GMCSF

EGFR vaccine with KLH

Experimental group

Description:

EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m

Treatment:

Biological: KLH