HER-2/Neu Vaccine Plus GM-CSF in Treating Patients With Stage III or Stage IV Breast, Ovarian, or Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00003002
First received: November 1, 1999
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian cancer, or stage III or stage IV non-small cell lung cancer.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Ovarian Cancer
Biological: HER-2/neu peptide vaccine
Biological: sargramostim
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers

Resource links provided by NLM:


Further study details as provided by University of Washington:

Enrollment: 60
Study Start Date: April 1996
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether immunity can be elicited with peptides derived from the intracellular domain of the HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by immunization with peptides derived from the HER-2/neu protein.

OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20 patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations. Patients receive a follow-up evaluation 1 month after the last vaccination. Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected.

PROJECTED ACCRUAL: 60 patients will be accrued.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast, ovarian, or nonsmall cell lung cancer (NSCLC): Adenocarcinoma No progressive disease May have comlpeted at least 1 standard chemotherapy regimen Confirmed HER-2/neu protein overexpression in tumor (either primary tumor or metastasis)

PATIENT CHARACTERISTICS: Age: Pre or postmenopausal Performance status: Not specified Life expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Other: No anergy (positive delayed type hypersensitivity response required to two or more common recall antigens) Female patients must be nonfertile Male patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 month since cytotoxic chemotherapy Endocrine therapy: At least 1 month since corticosteroid therapy Concurrent hormone therapy allowed Radiotherapy: Concurrent radiation therapy for local control of disease allowed (except as initial therapy for NSCLC) Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003002

Locations
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Study Chair: Mary (Nora) L. Disis, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00003002     History of Changes
Other Study ID Numbers: CDR0000065564, UW-100.1, NCI-V97-1259
Study First Received: November 1, 1999
Last Updated: December 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
stage III breast cancer
stage IV breast cancer
stage III non-small cell lung cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Breast Neoplasms
Ovarian Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 18, 2014