A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
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
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2
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
Patients are followed at 3 weeks.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
New Approaches to Neuroblastoma Treatment (NANT)
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Children's Hospital Boston||Boston, Massachusetts 02115|
|Texas Children's Hospital||Houston, Texas|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Childrens Memorial Hospital||Chicago, Illinois 60614|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|
|Riley Hospital for Children||Indianapolis, Indiana 46202|
|University of California at San Francisco - Comprehensive Cancer Center||San Francisco, California 94143-0875|
|Lucile Packard Children's Hospital Stanford University||Palo Alto, California 94304|
|New Approaches to Neuroblastoma Treatment (NANT)||Los Angeles, California 90027-6016|
|AFLAC Cancer Center and Blood Disorders Service||Atlanta, Georgia 30322|