131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat
Information source: New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuroblastoma
Intervention: 131I-MIBG (Radiation); Vincristine (Drug); Irinotecan (Drug); Vorinostat (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: New Approaches to Neuroblastoma Therapy Consortium Official(s) and/or principal investigator(s): Steven DuBois, MD, Study Chair, Affiliation: Dana-Farber Cancer Institute
Overall contact: Araz Marachelian, MD, Phone: 323-361-5687, Email: nantops@chla.usc.edu
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Objective tumor response
Secondary outcome: Delayed engraftmentOccurence of toxic death Grade 3 or greater non-hematologic toxicities
Eligibility
Minimum age: 2 Years.
Maximum age: 30 Years.
Gender(s): Both.
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.
Locations and Contacts
Araz Marachelian, MD, Phone: 323-361-5687, Email: nantops@chla.usc.edu
Childrens Hospital Los Angeles, Los Angeles, California 90027-0700, United States; Recruiting Araz Marachelian, MD, Phone: 323-361-5687, Email: amarachelian@chla.usc.edu
Lucile Salter Packer Children's Hospital, Palo Alto, California 94304, United States; Not yet recruiting Clare Twist, MD, Phone: 650-723-5535, Email: clare.twist@stanford.edu
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting Katherine Matthay, MD, Phone: 415-476-3831, Email: matthayK@peds.ucsf.edu
Children Hospital of Colorado, Aurora, Colorado 80045, United States; Recruiting Margaret Macy, MD, Phone: 720-777-8856, Email: Margaret.macy@childrenscolorado.org
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia 30322, United States; Not yet recruiting Kelly Goldsmith, MD, Phone: 404-785-0853, Email: kgoldsm@emory.edu
University of Chicago, Comer Children's Hospital, Chicago, Illinois 60637, United States; Recruiting Susan L. Cohn, MD, Phone: 773-702-2571, Email: Scohn@peds.bsd.uchicago.edu
Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting Suzanne Shusterman, MD, Phone: 617-632-4901
C.S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States; Recruiting Gregory Yanik, MD, Phone: 734-936-8785, Email: gyanik@umich.edu
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States; Not yet recruiting Stephen Roberts, MD, Phone: 212-639-4034, Email: robertss@mskcc.org
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States; Recruiting Brian Weiss, MD, Phone: 513-636-9863, Email: brian.weiss@chmcc.org
Hospital for Sick Children, Toronto, Ontario M5G1X8, Canada; Not yet recruiting Sylvain Baruchel, MD, Phone: 416-813-7795
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-4318, United States; Recruiting Yael Mosse, MD, Phone: 215-590-0965, Email: mosse@chop.edu
Cook Children's Healthcare System, Fort Worth, Texas 76104, United States; Recruiting Meaghan Granger, MD, Phone: 682-885-4007
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting Julie Park, MD, Phone: 206-987-1987
Additional Information
Starting date: July 2014
Last updated: August 14, 2015
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