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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov Identifier:
NCT02035137
First received: January 7, 2014
Last updated: March 21, 2017
Last verified: March 2017
  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.

Condition Intervention Phase
Neuroblastoma Radiation: 131I-MIBG Drug: Vincristine Drug: Irinotecan Drug: Vorinostat Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by New Approaches to Neuroblastoma Therapy Consortium:

Primary Outcome Measures:
  • Objective tumor response [ 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 following three arms: single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG.


Secondary Outcome Measures:
  • Delayed engraftment [ Time Frame: 43-71 days after study day 1. ]
    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.

  • Occurence of toxic death [ Time Frame: Days 43 to 50 after study day 1 ]
    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.

  • Grade 3 or greater non-hematologic toxicities [ Time Frame: day 43 - 50 after study day 1 ]
    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


Estimated Enrollment: 105
Study Start Date: July 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. 31I-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

  Eligibility

Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035137

Locations
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, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
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
Investigators
Study Chair: Steven DuBois, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov Identifier: NCT02035137     History of Changes
Other Study ID Numbers: N2011-01
Study First Received: January 7, 2014
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Vincristine
Vorinostat
3-Iodobenzylguanidine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Histone Deacetylase Inhibitors
Radiopharmaceuticals

ClinicalTrials.gov processed this record on July 28, 2017