Ovarian Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT00023634

Recruitment Status:

Terminated

Sponsor:

Southwest Oncology Group

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There are 12 Locations for this study

See Locations Near You

Bay Regional Medical Center
Bay City Michigan, 48708, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
St. Joseph Hospital Community Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center
Mt. Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98114, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Wooley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Wenatchee Valley Clinic
Wenatchee Washington, 98801, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT00023634

Recruitment Status:

Terminated

Sponsor:


Southwest Oncology Group

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