ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
NCT ID: NCT01592045
Last Updated: 2015-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
UTC ch14.18 for two courses and NCI ch14.18 for three courses
ch14.18 -NCI
25 mg/m\^2/day IV for four consecutive days
ch14.18-UTC
17.5 mg/m\^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2)
Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4.
Isotretinoin
Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).
Sequence 2
NCI ch14.18 for two courses and UTC ch14.18 for three courses
ch14.18 -NCI
25 mg/m\^2/day IV for four consecutive days
ch14.18-UTC
17.5 mg/m\^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2)
Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4.
Isotretinoin
Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).
Interventions
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ch14.18 -NCI
25 mg/m\^2/day IV for four consecutive days
ch14.18-UTC
17.5 mg/m\^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2)
Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4.
Isotretinoin
Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 8 years of age or younger at diagnosis of high-risk neuroblastoma
* Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy
\* Radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor
* Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:
\* No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
* Patient who have no tumor seen on the prior bone marrow, and then have ≤ 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible
* No more than 12 months from starting the first induction chemotherapy after diagnosis to the date of ASCT
\* For patients who became high-risk neuroblastoma after initial non-high risk disease, the 12 months period should start from the date of induction therapy for high-risk neuroblastoma to the date of ASCT
* No progressive disease at time of registration except for protocol-specified bone marrow response
* Adequate hematological, renal, hepatic, pulmonary and cardiac function
* CNS toxicity \< Grade 2
Exclusion Criteria
* Prior vaccine therapy for neuroblastoma
* Concurrent anti-cancer or immunosuppressive therapy
8 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Araz Marachelian, MD
Role: STUDY_CHAIR
Children's Hospital Los Angeles
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Children's Mercy Hospital (Kansas)
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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DIV-NB-201
Identifier Type: -
Identifier Source: org_study_id
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