131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
N2011-01
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
1 other identifier
interventional
114
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2014
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedResults Posted
Study results publicly available
June 8, 2022
CompletedJune 8, 2022
May 1, 2022
6.7 years
January 7, 2014
February 24, 2022
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Tumor Response After One Course of Therapy
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.
43-50 days from study day 1
Secondary Outcomes (1)
Number of Participants With Grade 3 or Greater Non-hematologic Toxicities
All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months
Study Arms (3)
Single-Agent 131I-MIBG
ACTIVE 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/Irinotecan
ACTIVE 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. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
131I-MIBG with Vorinostat
ACTIVE 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Lucile Salter Packer Children's Hospital
Palo Alto, California, 94304, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Children Hospital of Colorado
Aurora, Colorado, 80045, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322, United States
University of Chicago, Comer Children's Hospital
Chicago, Illinois, 60637, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
C.S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318, United States
Cook Children's Healthcare System
Fort Worth, Texas, 76104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
Related Publications (1)
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.
PMID: 34270348DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- NANT Medical Director
- Organization
- New Advances in Neuroblastoma Therapy
Study Officials
- STUDY CHAIR
Steven DuBois, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2014
First Posted
January 14, 2014
Study Start
July 1, 2014
Primary Completion
February 26, 2021
Study Completion
February 26, 2021
Last Updated
June 8, 2022
Results First Posted
June 8, 2022
Record last verified: 2022-05