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Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors

Primary Purpose

Melanoma (Skin), Neuroblastoma, Sarcoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
hu14.18-IL2 fusion protein
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

DG2 positive relapsed or refractory solid tumors

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Assess immunological changes associated with fusion protein therapy

Full Information

First Posted
November 1, 1999
Last Updated
August 6, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003750
Brief Title
Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Official Title
A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
metastatic osteosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent melanoma, unspecified childhood solid tumor, protocol specific, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DG2 positive relapsed or refractory solid tumors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
hu14.18-IL2 fusion protein
Primary Outcome Measure Information:
Title
Determine the MTD and pharmacokinetics of hu14.18-IL2 fusion protein
Description
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 Measure Information:
Title
Assess immunological changes associated with fusion protein therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M. Sondel, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5208
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Kansas Cancer Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Floating Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0914
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States
Facility Name
Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Hospital at State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Children's Hospital of Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children's Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
McGill University Health Center - Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16551859
Citation
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.
Results Reference
result

Learn more about this trial

Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors

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