Spots Global Cancer Trial Database for Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
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Trial Identification
Brief Title: Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
Official Title: A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
Study ID: NCT00054405
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
New Approaches to Neuroblastoma Treatment (NANT), Los Angeles, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
University of California at San Francisco - Comprehensive Cancer Center, San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service, Atlanta, Georgia, United States
Childrens Memorial Hospital, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Children's Hospital Boston, Boston, Massachusetts, United States
University of Michigan University Hospital, Ann Arbor, Michigan, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: Jon Wigginton
Affiliation: New Approaches to Neuroblastoma Treatment (NANT)
Role: PRINCIPAL_INVESTIGATOR
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