A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy

OBJECTIVES:

• Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors.
• Determine a range of biologically active doses of this drug in these patients.
• Determine the biological effects of this drug in these patients.
• Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
• Determine the antitumor effects of this drug in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive interleukin-7 (IL-7) subcutaneously on days 0, 2, 4, 6, 8, 10, 12, and 14 (for a total of 8 doses) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) and "biologically active dose" (BAD) are determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The BAD is defined as the dose that produces a sustained 50% increase in CD3+ count over the patient's baseline without unacceptable toxicity.