Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cytarabine; Fludarabine; Fludarabine phosphate; Immunoglobulins; Isotretinoin; Thymoglobulin; Tipifarnib

Criteria

Inclusion Criteria:

• Newly diagnosed, previously untreated juvenile myelomonocytic leukemia

• Presenting with all of the following:

• Absence of t(9;22) or bcr/abl by PCR

• Absolute monocyte count greater than 1,000/mm^3

• Less than 20% bone marrow blasts

• Presenting with at least 2 of the following:

• Elevated F hemoglobin

• Myeloid precursors in peripheral blood

• WBC greater than 10,000/mm^3

• Sargramostim (GM-CSF) hypersensitivity

• See Disease Characteristics

• Bilirubin no greater than 2.0 mg/dL

• ALT no greater than 3 times normal

• Creatinine no greater than 2 times normal

• No concurrent sargramostim (GM-CSF)

• No concurrent proton pump inhibitors