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
- Patients With Regimen-Related Toxicity [ Time Frame: Up to 30 Days Post Study Treatment ]