131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
NCT ID: NCT02035137
Last Updated: 2022-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2014-07-31
2021-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-Agent 131I-MIBG
Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.
131I-MIBG
131I-MIBG with Vincristine/Irinotecan
Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
131I-MIBG
Vincristine
Irinotecan
131I-MIBG with Vorinostat
Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
131I-MIBG
Vorinostat
Interventions
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131I-MIBG
Vincristine
Irinotecan
Vorinostat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with \> 3 residual lesions on end-induction MIBG scan.
* Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
* Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
* Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable CD34+ cells/kg available.
Exclusion Criteria
* They have other medical problems that could get much worse with this treatment.
* They are pregnant or breast feeding.
* They have a history of a venous or arterial thrombosis that was not associated to a central line.
* They have active infections such as hepatitis or fungal infections.
* They have active diarrhea.
* They have had an allogeneic stem cell transplant (received stem cell from someone else)
* They can't cooperate with the special precautions that are needed for this trial.
2 Years
30 Years
ALL
No
Sponsors
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New Approaches to Neuroblastoma Therapy Consortium
OTHER
Responsible Party
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Principal Investigators
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Steven DuBois, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Childrens Hospital Los Angeles
Los Angeles, California, United States
Lucile Salter Packer Children's Hospital
Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children Hospital of Colorado
Aurora, Colorado, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
University of Chicago, Comer Children's Hospital
Chicago, Illinois, United States
Children's Hospital Boston
Boston, Massachusetts, United States
C.S Mott Children's Hospital
Ann Arbor, Michigan, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Healthcare System
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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DuBois SG, Granger MM, Groshen S, Tsao-Wei D, Ji L, Shamirian A, Czarnecki S, Goodarzian F, Berkovich R, Shimada H, Villablanca JG, Vo KT, Pinto N, Mosse YP, Maris JM, Shusterman S, Cohn SL, Goldsmith KC, Weiss B, Yanik GA, Twist CJ, Irwin MS, Haas-Kogan DA, Park JR, Marachelian A, Matthay KK. Randomized Phase II Trial of MIBG Versus MIBG, Vincristine, and Irinotecan Versus MIBG and Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A Report From NANT Consortium. J Clin Oncol. 2021 Nov 1;39(31):3506-3514. doi: 10.1200/JCO.21.00703. Epub 2021 Jul 16.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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N2011-01
Identifier Type: -
Identifier Source: org_study_id
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