Clinical Trial: Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

Brief Summary:

RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, and methylprednisolone before or after transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects and best way to give high-dose cytarabine together with mitoxantrone in treating patients with juvenile myelomonocytic leukemia undergoing a second donor stem cell transplant.


Detailed Summary:

OBJECTIVES:

Primary

  • To determine the incidence of 1-year disease-free survival in patients with juvenile myelomonocytic leukemia and who is undergoing a repeat stem cell transplantation.

Secondary

  • To evaluate the incidence of regimen-related toxicity.
  • To evaluate the incidence of acute and chronic graft-versus-host-disease.
  • To evaluate the incidence of relapse.

OUTLINE:

  • Preparative cytoreductive therapy: Patients receive high-dose cytarabine IV over 2 hours on days -9 to -4 and mitoxantrone hydrochloride IV over 30 minutes on days -9 to -7.
  • Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day 0. Patients undergoing umbilical cord blood transplantation receive methylprednisolone (as graft failure prophylaxis) IV twice daily on days 5 to 19 followed by a taper every other day thereafter until day 25.
  • Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours every 8-12 hours or orally twice daily beginning on day -3 and continuing until day 50, followed by a taper to day 90, in the absence of GVHD. Patients undergoing nongenotypically identical bone marrow transplantation also receive methotrexate IV on day 1 beginning 24 hours after completion of stem cell infusion and on days 3, 6, and 11.
  • Post-transplantation isotretinoin therapy: Patients receive oral isotretinoin once daily beg
    Sponsor: Masonic Cancer Center, University of Minnesota

    Current Primary Outcome: Disease-free Survival [ Time Frame: 1 year ]

    Number of patients who were free of disease and alive at 1 year.


    Original Primary Outcome: 1-year disease-free survival

    Current Secondary Outcome:

    • Patients With Regimen-Related Toxicity [ Time Frame: Up to 30 Days Post Study Treatment ]
      Number of patients with adverse events related to treatment.
    • Patients With Graft-Versus-Host-Disease [ Time Frame: Up to 30 Days Post Study Treatment ]
      Number of patients who exhibited acute and/or chronic graft-versus-host disease.
    • Patients Who Relapsed [ Time Frame: 1 Year ]
      Number of patients whose disease relapsed.


    Original Secondary Outcome:

    • Incidence of regimen-related toxicity
    • Incidence of acute and chronic graft-versus-host-disease
    • Incidence of relapse


    Information By: Masonic Cancer Center, University of Minnesota

    Dates:
    Date Received: February 6, 2008
    Date Started: June 1999
    Date Completion:
    Last Updated: January 31, 2012
    Last Verified: January 2012