Clinical Trials /

131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat

NCT02035137

Description:

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat
  • 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

Clinical Trial IDs

  • ORG STUDY ID: N2011-01
  • NCT ID: NCT02035137

Conditions

  • Neuroblastoma

Interventions

DrugSynonymsArms
Vincristine131I-MIBG with Vincristine/Irinotecan
Irinotecan131I-MIBG with Vincristine/Irinotecan
VorinostatZolinza131I-MIBG with Vorinostat

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Single-Agent 131I-MIBGActive ComparatorSingle-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.
    131I-MIBG with Vincristine/IrinotecanActive ComparatorVincristine / 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. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
    • Vincristine
    • Irinotecan
    131I-MIBG with VorinostatActive ComparatorVorinostat / 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.
    • Vorinostat

    Eligibility Criteria

            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 diarhhea.
    
              -  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.
          
    Maximum Eligible Age:30 Years
    Minimum Eligible Age:2 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Objective tumor response
    Time Frame:43-50 days from study day 1
    Safety Issue:
    Description:To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the following three arms: single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG.

    Secondary Outcome Measures

    Measure:Delayed engraftment
    Time Frame:43-71 days after study day 1.
    Safety Issue:
    Description:To compare toxicity profiles associated with occurence of delayed engraftment defined as failure to achieve ANC >= 500/uL by day 43 and platelet count >= 20,000 by day 71 of protocol therapy in absence of progressive bone marrow metastatic disease for each of the following 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG.
    Measure:Occurence of toxic death
    Time Frame:Days 43 to 50 after study day 1
    Safety Issue:
    Description:To compare the occurence of toxic deaths for each of the following 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG.
    Measure:Grade 3 or greater non-hematologic toxicities
    Time Frame:day 43 - 50 after study day 1
    Safety Issue:
    Description: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

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:New Approaches to Neuroblastoma Therapy Consortium

    Last Updated

    August 19, 2019