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

Status: Active

Description

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.

Eligibility 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 & Contacts

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Clare J. Twist
Phone: 650-723-5535 Email: clare.twist@stanford.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Temporarily closed to accrual
Name Not Available

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Susan Lerner Cohn
Phone: 773-702-2571 Email: Scohn@peds.bsd.uchicago.edu

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Kelly C. Goldsmith
Phone: 404-785-0853 Email: kgoldsm@emory.edu

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Suzanne Shusterman
Phone: 617-632-4901

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Gregory A. Yanik
Phone: 734-936-8785 Email: gyanik@umich.edu

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: Active
Name Not Available

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Julie Ruggieri Park
Phone: 206-987-1987

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
New Approaches to Neuroblastoma Treatment (NANT)

Trial IDs

Primary ID N2011-01
Secondary IDs NCI-2015-00640
Clinicaltrials.gov ID NCT02035137