her-2/neu vaccine plus gm-csf in treating patients with stage iii or stage iv breast, ovarian, or non-small cell lung cancer

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer

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.

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 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

Keywords: 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