A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy
- 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.
Patients are followed at 1, 3, and 6 months and at 1 year after study completion.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3.75-10
Primary Purpose: Treatment
Claude Sportes, MD
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Methodist Hospital||Houston, Texas 77030|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|