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| ID | Type | Description | Link |
|---|---|---|---|
| COG-ADVL0018 | Other Identifier | Children's Oncology Group | |
| CDR0000066870 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DG2 positive relapsed or refractory solid tumors | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hu14.18-IL2 fusion protein | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess immunological changes associated with fusion protein therapy |
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DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or melanoma at original diagnosis
Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse
No primary CNS tumors
Prior CNS metastases allowed, provided:
No clinically detectable pleural effusions or ascites
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Paul M. Sondel, MD, PhD | University of Wisconsin, Madison | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16551859 | Result | 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. |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Stanford Cancer Center at Stanford University Medical Center | Stanford | California | 94305-5208 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Shands Cancer Center at the University of Florida Health Science Center | Gainesville | Florida | 32610-0296 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus | Atlanta | Georgia | 30342 | United States |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Kansas Cancer Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Floating Hospital for Children | Boston | Massachusetts | 02111 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0914 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Washington University Medical Center | St Louis | Missouri | 63105 | United States |
| Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| University Hospital at State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Columbus | Columbus | Ohio | 43205-2696 | United States |
| Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73126 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105-2794 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6838 | United States |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390-9063 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Texas Children's Cancer Center | Houston | Texas | 77030-2399 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
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| ID | Term |
|---|---|
| C493743 | lorukafusp alfa |
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