HER-2/Neu Vaccine Plus GM-CSF in Treating Patients With Stage III or Stage IV Breast, Ovarian, or Non-Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Lung Cancer; Ovarian Cancer
Intervention: HER-2/neu peptide vaccine (Drug); sargramostim (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Washington
Official(s) and/or principal investigator(s):
Mary (Nora) L. Disis, MD, Study Chair, Affiliation: University of Washington
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.
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
Study design: Treatment
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.
Minimum age: N/A.
Maximum age: N/A.
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
Locations and Contacts
University of Washington School of Medicine, Seattle, Washington 98195, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1996
Last updated: May 23, 2008