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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of R115777, Isotretinoin, Cytarabine, and Fludarabine Followed By Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia (R11577 portion of the study closed to accrual as of 08/2005)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Child	NCI	COG-AAML0122 NCT00025038, AAML0122

Trial Description

Purpose:

Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient’s immune system from rejecting the donor’s stem cells. When the healthy 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.

This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia.

Eligibility:

Eligibility criteria include the following:

• Child
• No previous treatment for juvenile myelomonocytic leukemia
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients may choose to receive R115777 by mouth twice a day for 3 weeks. After a 1-week rest period, they may receive a second course of R115777. (The optional R11577 portion of this study closed to accrual as of 08/2005). All patients will receive isotretinoin by mouth once a day until bone marrow or umbilical cord blood transplant. They will also receive infusions of fludarabine and cytarabine once a day for 5 days every 4 weeks for up to two courses. Patients will then undergo total-body irradiation twice a day on days 1-4, infusions of cyclophosphamide once a day on days 5 and 6, and a 4- to 6-hour infusion of antithymocyte globulin twice a day on days 5-7. Patients will undergo donor bone marrow or umbilical cord blood transplant on day 8. Within 9 weeks after transplant, patients will receive isotretinoin by mouth once a day for up to 1 year.

Patients will be evaluated every 6 months for 5 years and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Robert Castleberry, MD, Protocol chair		Ph: 205-939-9285; 800-822-0933 Email: rcastleberry@peds.uab.edu

Registry Information
Official Title		Phase II Window Evaluation of the Farnesyl Transferase Inhibitor (R115777) Followed by 13-CIS Retinoic Acid, Cytosine Arabinoside and Fludarabine Plus Hematopoietic Stem Cell Transplantation in Children with Juvenile Myelomonocytic Leukemia
Trial Start Date		2001-06-11
Registered in ClinicalTrials.gov		NCT00025038
Date Submitted to PDQ		2001-06-06
Information Last Verified		2006-10-20
NCI Grant/Contract Number		CA13539

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