S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00023634

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors Gastric Cancer Ovarian Cancer Prostate Cancer	Biological: EGFR antisense DNA Biological: keyhole limpet hemocyanin Biological: sargramostim	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Prostate Cancer Stomach Cancer

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	June 2001

Intervention Details:

500 mcg peptide w/GMCSF or KLH (2 equal injections) monthly x 6 mos

arm 2: 100 mcg w/EGFRvIII

arm 1: 100 mcg w/EGFRvIII

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

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023634

Locations

United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
United States, Washington
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Robert B. Montgomery, MD

Department of Veterans Affairs

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence Baker, DO, SWOG
ClinicalTrials.gov Identifier:	NCT00023634 History of Changes
Other Study ID Numbers:	CDR0000068824, U10CA032102, R01CA082661, S0114, UW-106, NCI-V01-1664
Study First Received:	September 13, 2001
Last Updated:	July 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Stomach Neoplasms
Nervous System Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Central Nervous System Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nervous System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012