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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 engraftment

Occurence 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

Page last updated: August 23, 2015

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