Overview

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients who have hematologic cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Treatments:
Antilymphocyte Serum
Busulfan
Cyclosporine
Cyclosporins
Melphalan
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignancy including: - Pediatric acute
lymphocytic leukemia (ALL) in first complete remission with high risk features including
presence of t(4;11) or t(9;22), or extreme hyperleukocytosis (initial WBC greater than 500
K/mL), or failure to achieve a complete remission after standard induction therapy - Adult
ALL or acute nonlymphoblastic leukemia (ANLL) in first complete remission with t(8;14)
translocation or failure to achieve complete remission after standard induction therapy -
ALL or ANLL in second or subsequent remission - Chronic myelogenous leukemia in chronic or
accelerated phase - Myelodysplastic syndrome with evidence of evolution to acute myeloid
leukemia Refractory anemia with excess blasts Refractory anemia with excess blasts in
transformation Chronic myelomonocytic leukemia - T-lymphoblastic non-Hodgkin's lymphoma in
second or subsequent remission - Stage IV neuroblastoma Must also meet all the following
conditions: No HLA-ABC/DR identical related bone marrow or UCB donor No 5/6 antigen matched
related bone marrow or UCB donor Condition precludes waiting to search and find a donor in
the National Marrow Donor Registry Must have an available serologic matched umbilical cord
blood unit in the New York Blood Center's Placental Blood Project No active CNS disease Not
eligible for COBLT study (Transplantation of Banked Umbilicial Cord Blood Cells for Use in
Clinical Research on Transplantation of Umbilical Cord Blood Stem and Progenitor Cells)

PATIENT CHARACTERISTICS: Age: Under 55 at time of umbilical cord blood transplantation
Performance status: Zubrod 0-1 Lansky 80-100% Karnofsky 80-100% Life expectancy: At least 3
months Hematopoietic: Adequate hematologic status at time of back-up bone marrow harvest:
WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least
100,000/mm3 Hepatic: ALT/AST no greater than 4 times normal Bilirubin no greater than 2.0
mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min
Cardiovascular: Normal cardiac function by echocardiogram or radionuclide scan (shortening
fraction or ejection fraction at least 80% of normal value for age) Pulmonary: FVC and FEV1
at least 60% of predicted for age For adults: DLCO at least 60% of predicted Other: No
active infections at time of back-up bone marrow harvest or pretransplant reduction Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified