A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
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.
Interventional
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)
28 days
Yes
Jon Wigginton
Principal Investigator
New Approaches to Neuroblastoma Treatment (NANT)
United States: Food and Drug Administration
NCI-2009-00024
NCT00054405
December 2002
Name | Location |
---|---|
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 |