NCT00054405

Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma

A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.

Detailed description

OBJECTIVES: I. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma. II. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients. III. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients. IV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 treatment cohorts. COHORT A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12. COHORT B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A. Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator. Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD. Patients are followed at 3 weeks.

Conditions

• Recurrent Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interleukin-12	Given IV
BIOLOGICAL	aldesleukin	Given IV

Timeline

• Start date: 2002-12-01
• Primary completion: 2009-05-01
• First posted: 2003-02-06
• Last updated: 2013-04-09

Locations

14 sites across 1 country: United States