Protocol Number: 06-C-0167
-Tumor necrosis factor (TNF) has anti-cancer effects, but in doses high enough to shrink tumors it causes serious side effects. -In studies in laboratory mice, TNF that was attached, or "bound," to microscopic gold particles collected in tumors and destroyed tumor cells with fewer side effects, because the higher TNF levels were only in the tumor and less of the drug was released into the blood. -Gold-bound TNF (CYT6091) is an experimental drug that has not been given to humans before. Objectives: -To determine the highest dose of CYT6091 that can safely be given to patients with solid tumors and to identify the drug's side effects. -To determine how the drug behaves in the body (how it is used and eliminated) and its effects on tumor tissue. Eligibility: -Patients 18 years of age or older with a solid tumor that has spread beyond the primary organ site. -Patients whose cancer cannot be treated successfully with standard therapies or for which conventional treatment is not available. Design: -Patients are admitted to the hospital for approximately 4 days for CYT6091 infusions. The drug is given through a catheter (plastic tube) that is threaded from a large arm vein to the heart. Doses are given 2 weeks apart; two doses are considered one treatment course. Patients whose tumor remains stable or shrinks after the first treatment course may be offered additional courses until their disease progresses or side effects become unacceptable. -Patients are evaluated throughout the study with tests to determine the size and extent of tumor and the impact of treatment. This includes periodic blood tests, physical examinations, scans and x-rays. Additional blood tests are done for research. After treatment ends, patients are followed with the same evaluations at longer intervals. -Patients with tumors that are easy to biopsy may be asked to undergo a biopsy to evaluate the amount of CYT6091 in the tumor. A piece of normal tissue next to the tumor is also biopsied. Additional biopsies may be requested in patients who receive additional courses of therapy. -Up to 60 patients may be enrolled in the study.
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