Clinical trial · Interventional
HER-2/Neu Vaccine Plus GM-CSF in Treating Patients With Stage III or Stage IV Breast, Ovarian, or Non-small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available