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131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat (N2011-01)

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ClinicalTrials.gov Identifier: NCT02035137
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : June 8, 2022
Last Update Posted : June 8, 2022
Information provided by (Responsible Party):
New Approaches to Neuroblastoma Therapy Consortium

Brief Summary:
This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Radiation: 131I-MIBG Drug: Vincristine Drug: Irinotecan Drug: Vorinostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma
Study Start Date : July 2014
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : February 26, 2021

Arm Intervention/treatment
Active Comparator: 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.
Radiation: 131I-MIBG
Other Names:
  • 131I-Metaiodobenzylguanidine
  • Iobenguane sulfate
  • m-Iodobenzylguanidine sulfate
  • MIBG

Active Comparator: 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.
Radiation: 131I-MIBG
Other Names:
  • 131I-Metaiodobenzylguanidine
  • Iobenguane sulfate
  • m-Iodobenzylguanidine sulfate
  • MIBG

Drug: Vincristine
Drug: Irinotecan
Active Comparator: 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.
Radiation: 131I-MIBG
Other Names:
  • 131I-Metaiodobenzylguanidine
  • Iobenguane sulfate
  • m-Iodobenzylguanidine sulfate
  • MIBG

Drug: Vorinostat
Other Name: Zolinza

Primary Outcome Measures :
  1. Objective Tumor Response After One Course of Therapy [ Time Frame: 43-50 days from study day 1 ]
    To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.

Secondary Outcome Measures :
  1. Number of Participants With Grade 3 or Greater Non-hematologic Toxicities [ Time Frame: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months ]
    Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be > 24 months and < 30 years of age when registered on study.
  • 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 had previous I-131 MIBG therapy
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035137

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United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Lucile Salter Packer Children's Hospital
Palo Alto, California, United States, 94304
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Children Hospital of Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago, Comer Children's Hospital
Chicago, Illinois, United States, 60637
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
C.S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Texas
Cook Children's Healthcare System
Fort Worth, Texas, United States, 76104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
New Approaches to Neuroblastoma Therapy Consortium
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Study Chair: Steven DuBois, MD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by New Approaches to Neuroblastoma Therapy Consortium:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov Identifier: NCT02035137    
Other Study ID Numbers: N2011-01
First Posted: January 14, 2014    Key Record Dates
Results First Posted: June 8, 2022
Last Update Posted: June 8, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Histone Deacetylase Inhibitors