Clinical trial · Interventional
Biological Therapy in Treating Patients With Advanced Cancer
A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies
- 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: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.
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 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu intracellular domain protein | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
- timeFrame
- 12 months
- description
- safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignancy that expresses HER2/neu * Stage IIA breast cancer with more than 6 positive lymph nodes * Stage IIB, IIIA, or IIIB breast cancer * Stage III ovarian cancer * Lymph node positive gastric cancer * Metastatic tumor * No measurable or evaluable disease after standard treatment * No previously irradiated or newly diagnosed CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * Greater than 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 mg/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * No hepatic disease, including viral hepatitis Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No asthma or chronic obstructive pulmonary disease Immunologic: * Must have positive intradermal delayed hypersensitivity test for at least 1 of the following: * Candida * Mumps * Tetanus * Trichophyton * Histoplasmin * No prior autoimmune disease including, but not limited to, the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Ankylosing spondylitis * Scleroderma * Multiple sclerosis Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * Hepatitis B surface antigen and hepatitis C antibody negative * No other concurrent serious chronic or acute illness or infection (including urinary tract infection) * No known shellfish or iodine allergy * No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer * No medical or psychological condition that may preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No other concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors) * At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine) Radiotherapy: * Prior radiotherapy allowed except to cranium * At least 4 weeks since prior radiotherapy and recovered * At least 12 weeks since prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * At least 4 weeks since prior surgery and recovered Other: * Concurrent bisphosphonates allowed * No prior hepatitis B immunization
References
Publications (1)
- RESULTMorse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, Anders C, Devi GR, Lyerly HK, Clay TM. Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2. J Transl Med. 2007 Sep 6;5:42. doi: 10.1186/1479-5876-5-42. PMID 17822557