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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003002
• Other study ID #: 14798
• Secondary ID: UW-100.1NCI-V97-
• Status: Completed
• Phase: Phase 1
• Start date: April 1996
• Est. completion date: January 2004

Study information

• Verified date: February 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Ovarian Cancer

Intervention

Biological:
• HER-2/neu peptide vaccine

• sargramostim

Locations

Country	Name	City	State
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States,