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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 30 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02035137
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

New Approaches to Neuroblastoma Therapy Consortium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven DuBois, MD
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroblastoma
Arms & Interventions

Arms

Active Comparator: Single-Agent 131I-MIBG

Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.

Active Comparator: 131I-MIBG with Vincristine/Irinotecan

Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.

Active Comparator: 131I-MIBG with Vorinostat

Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.

Interventions

Radiation: - 131I-MIBG

Drug: - Vincristine

Drug: - Irinotecan

Drug: - Vorinostat

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Childrens Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Childrens Hospital Los Angeles

Los Angeles, California, 90027-0700

Site Contact

Araz Marachelian, MD

amarachelian@chla.usc.edu

323-361-5687

Lucile Salter Packer Children's Hospital, Palo Alto, California

Status

Recruiting

Address

Lucile Salter Packer Children's Hospital

Palo Alto, California, 94304

Site Contact

Sheri Spunt, MD

nantops@chla.usc.edu

323-361-5687

San Francisco, California

Status

Recruiting

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Site Contact

Katherine Matthay, MD

matthayK@peds.ucsf.edu

415-476-3831

Children Hospital of Colorado, Aurora, Colorado

Status

Recruiting

Address

Children Hospital of Colorado

Aurora, Colorado, 80045

Site Contact

Margaret Macy, MD

Margaret.macy@childrenscolorado.org

720-777-8856

Atlanta, Georgia

Status

Recruiting

Address

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322

Site Contact

Kelly Goldsmith, MD

kgoldsm@emory.edu

404-785-0853

Chicago, Illinois

Status

Recruiting

Address

University of Chicago, Comer Children's Hospital

Chicago, Illinois, 60637

Site Contact

Ami Desai, MD

adesai12@peds.bsd.uchicago.edu

773-843-3943

Children's Hospital Boston, Boston, Massachusetts

Status

Recruiting

Address

Children's Hospital Boston

Boston, Massachusetts, 02115

Site Contact

Suzanne Shusterman, MD

nantops@chla.usc.edu

617-632-4901

C.S Mott Children's Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

C.S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Site Contact

Gregory Yanik, MD

gyanik@umich.edu

734-936-8785

University of North Carolina, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599

Site Contact

Patrick Thompson, MD

patom@email.unc.edu

323-361-5687

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

Site Contact

Brian Weiss, MD

brian.weiss@chmcc.org

513-636-9863

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318

Site Contact

Yael Mosse, MD

mosse@chop.edu

215-590-0965

Cook Children's Healthcare System, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Healthcare System

Fort Worth, Texas, 76104

Site Contact

Meaghan Granger, MD

nantops@chla.usc.edu

682-885-4007

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Navin Pinto, MD

navin.pinto@seattlechildrens.org

206-987-5783

International Sites

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto, Ontario, M5G1X8

Site Contact

Meredith Irwin, MD

nantops@chla.usc.edu

323-361-5687

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