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Haploidentical (half-matched) blood or marrow transplant (BMT) with reduced-intensity chemotherapy (chemo) to treat high-risk cancer that has come back (relapsed) or has not gotten better with treatment (refractory)

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Phase 2

4 Locations

NCT01804634

Clinical Trial Goal


To find out if reduced-intensity chemo and half-matched BMT is safe and works well to treat high-risk cancer that has relapsed or is refractory 

You may be able to join this trial if you:


  • Are 1 - 50 years old
  • Have one of the following cancers that doctors consider high risk that has relapsed or is refractory:
    • Brain tumor
    • Desmoplastic small round cell tumor
    • Ewing sarcoma
    • Hepatoblastoma
    • Melanoma
    • Neuroblastoma
    • Osteosarcoma
    • Other solid tumor or soft tissue sarcoma
    • Rhabdomyosarcoma
  • Have a family member who is a half match for you and can be your donor. Your biological parents and children are always a half-match for you. 
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cyclophosphamide, fludarabine and melphalan are drugs that block growth of cancer cells.
Mycophenolate mofetil (MMF) is a drug that slows down the immune system.
Tacrolimus is a standard drug used to prevent GVHD.

Before transplant, you’ll get standard chemo to prepare you. These drugs are given by intravenous (IV) infusions:
  • Fludarabine
  • Melphalan

You'll also have total body irradiation (TBI), a treatment to prepare your body for transplant.

On transplant day, blood-forming cells from your donor are given to you through an IV infusion.

After transplant you'll get standard drugs to prevent graft-versus-host disease (GVHD):
  • Cyclophosphamide
  • MMF
  • Tacrolimus

The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has approved all the drugs in this trial. Using half-matched BMT and reduced-intensity chemo in this way to treat these high-risk cancers that have relapsed or are refractory is new and unproven.

Contacts


Heather Symons, MD, MHS, 410-502-4997, hsymons2@jhmi.edu

Jasmine Brooks, BA, 667-306-8335, jbrook54@jhmi.edu

Locations


Johns Hopkins All Children's HospitalACTIVE_NOT_RECRUITING

St. Petersburg, Florida

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRECRUITING

Baltimore, Maryland
Heather Symons, MD, MHS, 410-502-4997, hsymons2@jhmi.edu

Albert Einstein College of Medicine, Children's Hospital at MontefioreRECRUITING

The Bronx, New York
David Loeb, MD, 718-839-7497, david.loeb@einstein.yu.edu

New York Medical Center/ Maria Fareri Children's HospitalRECRUITING

Valhalla, New York
Aliza Gardenswartz, MD, 914-594-2130, Aliza.Gardenswartz@wmchealth.org

ClinicalTrials.gov record


NCT01804634. First posted on 3/5/13

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