Clinical Trial Finder

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

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

Accepts Healthy Volunteers
No

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.

Study Type
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

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.

Trial ID:
NCT02035137

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

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
Phase 2

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

Lead Sponsor
New Approaches to Neuroblastoma Therapy Consortium

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

Agency Class
Other
Overall Status Recruiting
Countries Canada, United States

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

Conditions
Neuroblastoma

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

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

Susan L. Cohn, MD

Scohn@peds.bsd.uchicago.edu

773-702-2571

Children's Hospital Boston, Boston, Massachusetts

Status

Recruiting

Address

Children's Hospital Boston

Boston, Massachusetts, 02115

Site Contact

Suzanne Shusterman, MD

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

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

682-885-4007

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Julie Park, MD

206-987-1987

International Sites

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto, Ontario, M5G1X8

Site Contact

Meredith Irwin, MD

323-361-5687

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