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