Fallopian Tube Cancer Clinical Trial
Official title:
A Phase I Trial of Herceptin and Interleukin-12
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
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Medical Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Up to 52 weeks | Yes |
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