hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Biological: hu14.18-Interleukin-2 fusion protein
- Registration Number
- NCT00082758
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.
- Detailed Description
OBJECTIVES:
* Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu14.18-interleukin-2 (hu14.18-IL2) fusion protein.
* Determine the adverse events of this drug in these patients.
* Determine the immunologic activation in patients treated with this drug.
* Determine the induction of anti-hu14.18-IL2 antibody in patients treated with this drug.
* Correlate antitumor response with measurements of toxicity, immune activation, and anti-hu14.18-IL2 antibody activity in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to measurable/evaluable disease (measurable by standard radiographic criteria vs evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry).
For standard radiographic criteria this study will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. Complete Response (CR) - Disappearance of all target lesions. No evidence of tumor at any site (chest, abdomen, liver, bone, bone marrow, nodes, etc). Very Good Partial Response (VGPR) - Greater than 90% decrease of the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry; all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Partial Response (PR) - At least a 30% decrease in the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry. Progressive Disease (PD) - Any one of the following: a) At least a 20% increase in the disease measurement for CT/MRI target lesions, taking as reference the smallest disease measurement recorded since the start of treatment. b) Appearance of one or more new lesions or new sites of tumor. c) PD as defined above for either bone marrow or MIBG lesions.
Stable disease (SD) - The patient will be classified as stable disease for overall response if there is stable disease by either CT/MRI lesion, bone marrow, or MIBG criteria. No new lesions; no new sites of disease.
Patients will be enrolled in 3 strata, and evaluated for antitumor response following 2 monthly courses (treatment on Days 1-3, followed by 25 days of observation,). Patients with progressive disease will be taken off protocol therapy. Patients with stabilization or regression of disease will be eligible to receive 2 more monthly courses of treatment. Additional treatment following course 4 will be allowed for patients showing a continued clinical response, up to a maximum of 10 courses of treatment.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40-60 patients (20 for strata 1 and 2 and 0-20 for stratum 3) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) hu14.18-Interleukin-2 fusion protein Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology. hu14.18-Interleukin-2 fusion protein : Given IV Disease Identified by BM Immunohistochemistry Only hu14.18-Interleukin-2 fusion protein Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV Disease Measurable by Standard Criteria(hu14.18-interleukin-2) hu14.18-Interleukin-2 fusion protein Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV
- Primary Outcome Measures
Name Time Method Number of Responders (Response Rate) Up to 30 weeks Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (81)
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Carilion Cancer Center of Western Virginia
🇺🇸Roanoke, Virginia, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Stanford Comprehensive Cancer Center - Stanford
🇺🇸Stanford, California, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
T.C. Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸Amarillo, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Floating Hospital for Children at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital Cancer Center
🇺🇸Denver, Colorado, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States