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Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of the HER2/neu Protein



Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of the HER2/neu Protein

For Condition: Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of the HER2/neu protein and has not responded to previous therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-12 (IL-12) when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies. II. Determine the safety of this regimen in these patients. III. Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen. IV. Characterize natural killer cytokine production in patients treated with this regimen. V. Determine serum interferon gamma levels in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study of interleukin-12 (IL-12). 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. Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter for survival. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignancy with overexpression of HER2-Neu (1-3+); Must have failed standard curative and/or palliative therapies - Measurable or evaluable disease - No concurrent brain or CNS metastases - No significant prior CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior trastuzumab - Chemotherapy: At least 3 weeks since prior chemotherapy - Endocrine therapy: At least 3 weeks since prior hormonal therapy; No concurrent systemic corticosteroids - Radiotherapy: At least 3 weeks since prior radiotherapy - Surgery: At least 3 weeks since prior surgery - Other: At least 3 weeks since prior investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Hemoglobin at least 9 g/dL (epoetin alfa or prior transfusion allowed); Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT and SGPT no greater than 3 times ULN; Hepatitis B surface antigen negative - Renal: Creatinine no greater than 1.5 times ULN; Creatinine clearance at least 60 mL/min; Calcium no greater than 11 mg/dL (calcium lowering agents allowed) - Cardiovascular: Cardiac ejection fraction normal by echocardiogram or MUGA; No active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention; No prior coronary artery disease; No prior congestive heart failure - Gastrointestinal: No clinically significant gastrointestinal bleeding; No uncontrolled peptic ulcer disease; No prior inflammatory bowel disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception before and during study; HIV negative; No other concurrent malignancy except nonmelanomatous skin cancer; No significant prior peripheral neuropathy; No serious concurrent infection requiring IV antibiotic therapy; No clinically significant autoimmune disease (e.g., rheumatoid arthritis); No other major illness that would increase risk
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamCarson,  Study Chair,  Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 


Additional Information:
Study ID Numbers:  CDR0000067282;  OSU-99H0185,NCI-T99-0032
Study Start Date: July 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004074

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