NCT00062049

Interleukin-7 in Treating Patients With Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors.

Detailed description

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. 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 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interleukin-7

Timeline

• Start date: 2003-04-01
• Completion: 2011-05-01
• First posted: 2003-06-06
• Last updated: 2012-03-08

Locations

3 sites across 1 country: United States