hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Neuroblastoma
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed neuroblastoma Relapsed or refractory to conventional therapy Measurable or evaluable disease documented by 1 of the following criteria: Clinical Radiographic Histologic MIBG (meta-iodobenzylguanidine) scanning Immunocytochemistry No symptomatic pleural effusions or ascites requiring constant or intermittent drainage No clinical or radiological evidence of central nervous system (CNS) disease PATIENT CHARACTERISTICS: Age 21 and under Performance status Karnofsky 50-100% (> 16 years of age) Lansky 50-100% (≤ 16 years of age) Life expectancy At least 8 weeks Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count ≥ 75,000/mm^3* Must not be refractory to platelet transfusions Hemoglobin ≥ 9.0 g/dL* NOTE: *Transfusion allowed if patient is known to have a history of bone marrow involvement with tumor Hepatic Alanine transaminase (ALT) < 2.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN Hepatitis B surface antigen negative Renal Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular Shortening fraction ≥ 27% by echocardiogram OR Ejection fraction ≥ 50% by Multi Gated Acquisition Scan (MUGA) No symptomatic congestive heart failure No uncontrolled cardiac rhythm disturbance Pulmonary Pulse oximetry > 94% on room air Forced vital capacity (FVC) > 80% Forced expiratory volume (FEV_1) > 80% No abnormal respiratory function No dyspnea at rest No exercise intolerance No prior history of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, or capillary leakage) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active uncontrolled infection No active uncontrolled peptic ulcer No objective peripheral neuropathy ≥ grade 2 No significant psychiatric disabilities No seizure disorders requiring antiseizure medications No other concurrent significant illness PRIOR CONCURRENT THERAPY: Biologic therapy Recovered from prior immunotherapy Prior in vivo monoclonal antibodies for biologic therapy or tumor imaging allowed provided there is documented absence of detectable antibody to hu14.18 by serology More than 28 days since prior autologous stem cell transplantation Prior autologous marrow or stem cell infusion using monoclonal antibody-purged specimens allowed More than 1 week since prior growth factors At least 7 days since prior nonmyelosuppressive biologic agents No prior allogeneic bone marrow or stem cell transplantation No concurrent immunomodulating agents No concurrent growth factors Chemotherapy More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered No concurrent anticancer chemotherapy Endocrine therapy No concurrent corticosteroids except 100 mg or less of hydrocortisone (or equivalent) as premedication for blood transfusion or treatment for transfusion reaction No other use of systemic steroids Radiotherapy Recovered from prior radiotherapy At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 months since prior craniospinal radiotherapy At least 6 months since prior total body irradiation At least 6 months since prior radiotherapy to ≥ 50% of the pelvis At least 6 weeks since other prior substantial bone marrow radiotherapy Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable or evaluable lesion is not irradiated Surgery More than 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy) No prior organ allografts Other No concurrent immunosuppressive drugs No other concurrent myelosuppressive antineoplastic drugs
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Childrens Hospital Los Angeles
- Children's Hospital Central California
- Children's Hospital of Orange County
- Sutter Cancer Center
- UCSF Comprehensive Cancer Center
- Stanford Comprehensive Cancer Center - Stanford
- Children's Hospital Cancer Center
- Children's National Medical Center
- University of Florida Shands Cancer Center
- Sacred Heart Cancer Center at Sacred Heart Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- MBCCOP - Medical College of Georgia Cancer Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Southern Illinois University School of Medicine
- Indiana University Melvin and Bren Simon Cancer Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Kosair Children's Hospital
- Tulane Cancer Center Office of Clinical Research
- CancerCare of Maine at Eastern Maine Medial Center
- Floating Hospital for Children at Tufts - New England Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Barbara Ann Karmanos Cancer Institute
- Spectrum Health Hospital - Butterworth Campus
- Breslin Cancer Center at Ingham Regional Medical Center
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Cancer Center at University of Minnesota
- University of Mississippi Cancer Clinic
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- University of New Mexico Cancer Research and Treatment Center
- Roswell Park Cancer Institute
- New York Medical College
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Oklahoma University Cancer Institute
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Palmetto Health South Carolina Cancer Center
- T.C. Thompson Children's Hospital
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- University of Texas Health Science Center at San Antonio
- Primary Children's Medical Center
- Virginia Commonwealth University Massey Cancer Center
- Carilion Cancer Center of Western Virginia
- Providence Cancer Center at Sacred Heart Medical Center
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Midwest Children's Cancer Center
- Alberta Children's Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Disease Measurable by Standard Criteria(hu14.18-interleukin-2)
Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)
Disease Identified by BM Immunohistochemistry Only
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
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
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