Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Melanoma (Skin), Neuroblastoma, Sarcoma

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring metastatic osteosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent melanoma, unspecified childhood solid tumor, protocol specific, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed neuroblastoma or melanoma at original diagnosis Refractory to chemotherapy or recurrence after prior multiagent chemotherapy Measurable or evaluable (detectable by bone scan) metastatic disease OR No evidence of disease if complete response to prior surgical resection, radiotherapy, and/or chemotherapy OR Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse Refractory to standard treatment Measurable or evaluable disease by clinical assessments or laboratory markers OR No evidence of disease after prior surgical resection of metastatic, recurrent disease Histologically confirmed recurrent osteogenic sarcoma after prior chemotherapy allowed Soft tissue sarcoma allowed No primary CNS tumors Prior CNS metastases allowed, provided: Disease previously treated Disease clinically stable for 4 weeks before study At least 4 weeks since prior steroids for CNS metastases No clinically detectable pleural effusions or ascites PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 60-100% for children over age 10 Lansky 60-100% for children age 10 and under Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count at least 75,000/mm^3 (transfusion allowed) Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL ALT or AST no greater than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min Cardiovascular: Shortening fraction at least 27% by echocardiogram OR Ejection fraction more than 50% by MUGA scan No congestive heart failure No uncontrolled cardiac rhythm disturbance Pulmonary: FEV_1 and FVC more than 60% of predicted OR No dyspnea at rest No exercise intolerance Oxygen saturation more than 94% by pulse oximetry on room air Neurologic: No seizure disorders requiring antiseizure medications No significant neurologic deficit or grade 2 or greater objective peripheral neuropathy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No significant concurrent illnesses unrelated to cancer or its treatment No significant psychiatric disabilities No uncontrolled active infections No uncontrolled active peptic ulcer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior growth factors At least 1 week since prior immunomodulatory therapy Prior monoclonal antibodies allowed if no detectable antibody to hu14.18 Prior autologous bone marrow transplantation (BMT) or stem cell transplantation (SCT) allowed Prior autologous BMT or SCT with monoclonal antibody-purged specimens allowed No concurrent growth factors No concurrent interferon Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan) No concurrent palliative chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior glucocorticoids, except for life-threatening symptoms No concurrent corticosteroids No concurrent glucocorticoids, except for life-threatening symptoms Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy) No prior organ allografts No concurrent palliative surgery Other: Recovered from prior therapy At least 1 week since prior tretinoin At least 3 weeks since prior immunosuppressive therapy No other concurrent immunosuppressive drugs
Sites / Locations
- Arkansas Children's Hospital
- University of Arkansas for Medical Sciences
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Children's Hospital Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital of Orange County
- UCSF Comprehensive Cancer Center
- Stanford Cancer Center at Stanford University Medical Center
- Children's National Medical Center
- Shands Cancer Center at the University of Florida Health Science Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
- Children's Memorial Hospital - Chicago
- Indiana University Cancer Center
- Kansas Cancer Institute at the University of Kansas Medical Center
- MBCCOP - LSU Health Sciences Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Children's Hospital of Michigan
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- Washington University Medical Center
- Cancer Center at Hackensack University Medical Center
- Robert Wood Johnson Medical School
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- University Hospital at State University of New York - Upstate Medical University
- Duke Comprehensive Cancer Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Columbus
- Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- CCOP - Columbia River Oncology Program
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Texas Children's Cancer Center
- University of Texas - MD Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Children's Hospital and Regional Medical Center - Seattle
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
- Midwest Children's Cancer Center
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Hospital for Sick Children
- McGill University Health Center - Montreal Children's Hospital
- Hopital Sainte Justine
Arms of the Study
Arm 1
Experimental
DG2 positive relapsed or refractory solid tumors
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.