Clinical trial · Interventional
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
A Phase I Trial of Herceptin and Interleukin-12
- 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)
Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy
Conditions
Conditions (127)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Anaplastic Thyroid Cancer | Thyroid Gland Anaplastic Carcinoma | ALIAS | 0.90 |
| Bone Metastases | — | UNRESOLVED | — |
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Distal Urethral Cancer | Distal Urethral Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gastrinoma | Gastrin-Producing Neuroendocrine Tumor | ALIAS | 0.90 |
| Glucagonoma | Pancreatic Glucagonoma | ALIAS | 0.90 |
| Inflammatory Breast Cancer | Breast Inflammatory Carcinoma | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-007/carboplatin/trastuzumab | Biological | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IL12 and trastuzumab)
- description
- Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week. Patients receive IL-12 IV on days 2 and 5 beginning on week 3. Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease continue treatment for up to 38 additional weeks.
- interventionNames
- Biological: recombinant interleukin-12
- Biological: ABI-007/carboplatin/trastuzumab
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)
- timeFrame
- Up to 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically proven Her2 overexpressing malignancy as determined by any standardized assay currently in clinical use * Patients must have measurable or evaluable disease * The patient must have failed standard curative and/or palliative therapies for their disease * Life expectancy of at least 6 months * No concurrent malignancy other than non-melanoma skin carcinoma * Adequate hematopoietic, cardiac, renal, and hepatic function * Calculated creatinine clearance will be used to assess renal function * Karnofsky Performance Status index \>= 70% * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; a woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant * Normal cardiac ejection fraction by echocardiogram or MUGA (i.e., greater than OSU lower limit of normal) * Written signed informed consent; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts Exclusion Criteria: * History of significant peripheral neuropathy or significant central nervous system disease * Brain or central nervous system metastasis at entry * Active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention; history of coronary artery disease or congestive heart failure * Pregnant or nursing women * Surgery, radiotherapy, chemotherapy, or hormonal therapy during the three weeks prior to the initiation of therapy * Exposure to any investigational drug within three weeks prior to the start of dosing * Concurrent use of systemic corticosteroids * Known seropositive for hepatitis B surface antigen * Known seropositive for HIV antibody * Serious concurrent infection requiring intravenous antibiotic therapy * Clinically significant autoimmune disease (e.g., rheumatoid arthritis) * Clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease * History of inflammatory bowel disease * Any other major illness which, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study * Prior therapy with Herceptin
References
Publications (0)
Data not yet available