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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Tumors Gastric Cancer Ovarian Cancer Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EGFR vaccine with GMCSF

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

Group Type EXPERIMENTAL

GMCSF

Intervention Type BIOLOGICAL

arm 1: 100 mcg w/EGFRvIII

EGFR vaccine with KLH

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

Group Type EXPERIMENTAL

KLH

Intervention Type BIOLOGICAL

100 mcg w/EGFRvIII

Interventions

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KLH

100 mcg w/EGFRvIII

Intervention Type BIOLOGICAL

GMCSF

arm 1: 100 mcg w/EGFRvIII

Intervention Type BIOLOGICAL

Other Intervention Names

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keyhole limpet sargramostim

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert B. Montgomery, MD

Role: STUDY_CHAIR

VA Puget Sound Health Care System

Locations

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Bay Regional Medical Center

Bay City, Michigan, United States

Site Status

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Site Status

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, United States

Site Status

Olympic Hematology and Oncology

Bremerton, Washington, United States

Site Status