Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have solid tumors. 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Interleukin-12; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed)

• Measurable or evaluable disease

• Failed standard curative therapy

• No brain or CNS metastasis

• Hormone receptor status:

• Not specified

• Male or female

• Performance status - Karnofsky 70-100%

• At least 6 months

• Absolute neutrophil count at least 1,500/mm^3

• Hemoglobin at least 8 g/dL (transfusion or epoetin alfa allowed)

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 3.0 times ULN

• Hepatitis B surface antigen negative

• Creatinine no greater than 1.5 times ULN

• Calcium no greater than 11 mg/dL (calcium-lowering agents allowed)

• No active or unstable cardiovascular disease

• No cardiac disease requiring drug or device intervention

• No coronary artery disease

• No congestive heart failure

• Cardiac ejection fraction normal by echocardiogram or MUGA scan

• No significant peripheral neuropathy

• No significant CNS disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No serious concurrent infection requiring IV antibiotic therapy

• No clinically significant autoimmune disease (e.g., rheumatoid arthritis)

• No clinically significant gastrointestinal bleeding

• No uncontrolled peptic ulcer disease

• No inflammatory bowel disease

• No other major illness that would preclude study participation

• No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix

• No prior interleukin-12

• No prior trastuzumab (Herceptin®)

• At least 3 weeks since prior chemotherapy

• At least 3 weeks since prior hormonal therapy

• No concurrent systemic corticosteroids

• At least 3 weeks since prior radiotherapy

• At least 3 weeks since prior surgery

• At least 3 weeks since prior investigational drug