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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00023634

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arms

Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumors Gastric Cancer Ovarian Cancer Prostate Cancer	Biological: KLH Biological: GMCSF	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EGFR vaccine with GMCSF EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m	Biological: GMCSF arm 1: 100 mcg w/EGFRvIII Other Names: sargramostim
Experimental: EGFR vaccine with KLH EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m	Biological: KLH 100 mcg w/EGFRvIII Other Names: keyhole limpet

Arm

Intervention/Treatment

Experimental: EGFR vaccine with GMCSF

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

Biological: GMCSF

arm 1: 100 mcg w/EGFRvIII

Other Names:

sargramostim

Experimental: EGFR vaccine with KLH

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

Biological: KLH

100 mcg w/EGFRvIII

Other Names:

keyhole limpet

Outcome Measures

Primary Outcome Measures

toxicity [during treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bay Regional Medical Center	Bay City	Michigan	United States	48708
2	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
3	St. Joseph Hospital Community Cancer Center	Bellingham	Washington	United States	98225
4	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
5	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington	United States	98273
6	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
7	Harborview Medical Center	Seattle	Washington	United States	98104
8	Group Health Central Hospital	Seattle	Washington	United States	98112
9	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98114
10	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
11	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington	United States	98284
12	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
13	Wenatchee Valley Clinic	Wenatchee	Washington	United States	98801