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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:2 - 30
Updated:8/4/2018
Start Date:July 2014
End Date:December 2019
Contact:Araz Marachelian, MD
Email:nantops@chla.usc.edu
Phone:323-361-5687

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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

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.


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.
We found this trial at
14
sites
Boston, Massachusetts 02115
Phone: 617-632-4901
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
Phone: 734-936-8785
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1405 Clifton Road Northeast
Atlanta, Georgia 30322
(404) 785-6000
Phone: 404-785-0853
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus...
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5721 S. Maryland Avenue
Chicago, Illinois 60637
Phone: 773-843-3943
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-9863
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-5687
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-0965
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
Phone: 415-476-3831
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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Aurora, Colorado 80045
Phone: 720-777-8856
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Fort Worth, Texas 76104
Phone: 682-885-4007
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Palo Alto, California 94304
Phone: 650-723-5535
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-5783
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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555 University Avenue
Toronto, Ontario M5G 1X8
Phone: 416-813-7795
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