Clinical trial NCT00023634: S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
Official title: An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Brain Tumors
Gastric Cancer
Ovarian Cancer
Prostate Cancer
Keywords: 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
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: toxicity
timeFrame: during treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Port Huron
country: United States
facility: Mercy Regional Cancer Center at Mercy Hospital
state: Michigan
city: Bellingham
country: United States
facility: St. Joseph Hospital Community Cancer Center
state: Washington
city: Bremerton
country: United States
facility: Olympic Hematology and Oncology
state: Washington
city: Mt. Vernon
country: United States
facility: Skagit Valley Hospital Cancer Care Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Group Health Central Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
state: Washington
city: Seattle
country: United States
facility: University Cancer Center at University of Washington Medical Center
state: Washington
city: Sedro-Wooley
country: United States
facility: North Puget Oncology at United General Hospital
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest - Spokane South
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Clinic
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Robert B. Montgomery, MD
role: STUDY_CHAIR
References: