Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Recruitment status was Active, not recruiting
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.
Unspecified Childhood Solid Tumor, Protocol Specific
Biological: hu14.18-IL2 fusion protein
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors|
|Study Start Date:||May 2001|
- Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors.
- Determine the toxicity and pharmacokinetics of the fusion protein in these patients.
- Determine the effect of the fusion protein on systemic immune modulation in these patients.
- Quantitate the antifusion protein antibodies in patients treated with fusion protein.
- Evaluate antitumor responses resulting from this fusion protein regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is 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.
Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003750
Show 59 Study Locations
|Study Chair:||Paul M. Sondel, MD, PhD||University of Wisconsin, Madison|