Interleukin-7 in Treating Patients With Refractory Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00062049
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-06-05
• Study First Submitted QC: 2003-06-05
• Study First Posted: 2003-06-06
• Study Completion: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States

NCI - Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Methodist Hospital; 🇺🇸 Houston, Texas, United States