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.
Checked against the public recordLast updated Feb 27, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Washington
- Interventions being studied
- Biological: HER-2/neu peptide vaccine; Biological: sargramostim
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Washington School of MedicineSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 27, 2019. Always confirm current availability with the study team.