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

Completed · Phase 1

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Recurrent Endometrial Carcinoma, Recurrent Gastric Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00028535

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2001-11-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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