Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
NCT ID: NCT00003750
Last Updated: 2014-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2001-10-31
2005-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
hu14.18-IL2 fusion protein
Interventions
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hu14.18-IL2 fusion protein
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Paul M. Sondel, MD, PhD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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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 D.C., District of Columbia, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
Atlanta, Georgia, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University Medical Center
St Louis, Missouri, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 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
Texas Children's Cancer Center
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
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References
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Osenga KL, Hank JA, Albertini MR, Gan J, Sternberg AG, Eickhoff J, Seeger RC, Matthay KK, Reynolds CP, Twist C, Krailo M, Adamson PC, Reisfeld RA, Gillies SD, Sondel PM; Children's Oncology Group. A phase I clinical trial of the hu14.18-IL2 (EMD 273063) as a treatment for children with refractory or recurrent neuroblastoma and melanoma: a study of the Children's Oncology Group. Clin Cancer Res. 2006 Mar 15;12(6):1750-9. doi: 10.1158/1078-0432.CCR-05-2000.
Other Identifiers
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COG-ADVL0018
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066870
Identifier Type: OTHER
Identifier Source: secondary_id
ADVL0018
Identifier Type: -
Identifier Source: org_study_id
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