vaccine therapy plus sargramostim in treating patients with stage iii or stage iv cancer

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer

Summary: rationale: vaccines may make the body build an immune response to tumor cells. colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. purpose: phase i trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage iii or stage iv cancer.

objectives: i. determine the safety of serial intradermal or subcutaneous vaccinations of her-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (plg) microspheres with adjuvant sargramostim (gm-csf) in patients with stage iii or iv her-2 expressing cancers. ii. determine whether cytotoxic t lymphocytes (ctl) specific for the her-2 protein can be elicited in patients with hla-a2 by immunization with this regimen. iii. determine which route of immunization, intradermal or subcutaneous, is more effective in generating her-2 specific ctl in these patients on this regimen. iv. determine the extent to which escalated dose of plg peptide affects the immune response in these patients on this regimen. outline: patients undergo leukapheresis prior to study and after final vaccination. patients are sequentially entered into one of three treatment arms: arm i: patients receive an intradermal vaccination of her-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (plg) microspheres with adjuvant sargramostim (gm-csf). arm ii: patients receive a subcutaneous vaccination of her-2 derived p369-377 peptide incorporated into plg microspheres with adjuvant gm-csf. arm iii: patients receive a higher dose of subcutaneous vaccination of her-2 derived p369-377 peptide incorporated into plg microspheres with adjuvant gm-csf. treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity. projected accrual: a total of 15 patients (5 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: stage iii adenocarcinoma that overexpresses her-2 and previously treated by surgical resection, conventional chemotherapy, or radiotherapy or stage iv adenocarcinoma that overexpresses her-2 and in stable or complete remission with no other concurrent chemotherapy must have documented her-2 protein overexpression in the primary or metastatic tumor hla-a2 positive patient characteristics: age: 18 and over performance status: karnofsky 90-100% 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 or creatinine clearance greater than 60 ml/min other: female patients must have completed childbearing fertile male patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 4 weeks since prior cytotoxic chemotherapy endocrine therapy: at least 4 weeks since prior corticosteroids radiotherapy: see disease characteristics surgery: see disease characteristics other: no other concurrent investigational phase i studies

Keywords: stage iv breast cancer stage iiia breast cancer stage iii non-small cell lung cancer stage iiib breast cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer stage iv non-small cell lung cancer adenocarcinoma of the lung