Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
Advanced Adult Primary Liver Cancer, Anaplastic Thyroid Cancer, Bone Metastases
About this trial
This is an interventional treatment trial for Advanced Adult Primary Liver Cancer
Eligibility Criteria
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
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (IL12 and trastuzumab)
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.