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)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
🇺🇸Atlanta, Georgia, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Texas Children's Cancer Center
🇺🇸Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Kansas Cancer Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States