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

a study on Neuroblastoma

Summary

for people ages 2-30 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Katherine Matthay

Description

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.

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

Keywords

Neuroblastoma Irinotecan Vincristine Vorinostat 3-Iodobenzylguanidine 131I-MIBG Single-Agent 131I-MIBG

Eligibility

You can join if…

Open to people ages 2-30

  • 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 CAN'T join 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 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.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • Lucile Salter Packer Children's Hospital accepting new patients
    Palo Alto California 94304 United States

Lead Scientist

  • Katherine Matthay
    Dr. Katherine Matthay is the chief of Pediatric Hematology-Oncology at UCSF Benioff Children's Hospital and has been focused for more than 20 years on translational research in neuroblastoma, a deadly childhood cancer. At UCSF, she has developed and led multiple trials using a unique targeted radiopharmaceutical, 131I-MIBG for neuroblastoma.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New Approaches to Neuroblastoma Therapy Consortium
ID
NCT02035137
Phase
Phase 2
Study Type
Interventional
Last Updated