Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
- Conditions
- NeuroblastomaSarcomaMelanoma (Skin)Unspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Biological: hu14.18-IL2 fusion protein
- Registration Number
- NCT00003750
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DG2 positive relapsed or refractory solid tumors hu14.18-IL2 fusion protein The initial hu14.18-IL2 fusion protein (FP) dose will be 2 mg/m2 given intravenously over 4 hours, daily for 3 days. Five separate dose levels are scheduled: 2 mg/m²/dose (IV over 4 hours) x 3 days, 4 mg/m²/dose (IV over 4 hours) x 3 days, 6 mg/m²/dose (IV over 4 hours) x 3 days, 8 mg/m²/dose (IV over 4 hours) x 3 days, 10 mg/m²/dose (IV over 4 hours) x 3 days.
- Primary Outcome Measures
Name Time Method Determine the MTD and pharmacokinetics of hu14.18-IL2 fusion protein Determine the MTD of hu14.18-IL2 fusion protein and determine the pharmacokinetics of the fusion protein when given as I.V. injections
- Secondary Outcome Measures
Name Time Method Assess immunological changes associated with fusion protein therapy
Trial Locations
- Locations (59)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (49 remaining)Arkansas Children's Hospital🇺🇸Little Rock, Arkansas, United States