Overview

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

Status:
Completed
Trial end date:
2017-10-16
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 allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients with hematologic cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Treatments:
Antilymphocyte Serum
Busulfan
Cyclophosphamide
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy Acute lymphocytic
leukemia (ALL): In second or later remission In first remission with poor prognostic
features (Philadelphia chromosome positive) Acute myeloid leukemia (AML): In second or
later remission In first remission with poor prognostic features, e.g., Arising from
myelodysplastic syndrome Cytogenetics with -5, -7, +8, 11q23 abnormalities Complex
cytogenetics AML or ALL refractory to induction or in relapse Myelodysplastic syndrome
Chronic myelogenous leukemia Severe aplastic anemia or Fanconi's anemia Relapsed Hodgkin's
disease Relapsed non-Hodgkin's lymphoma Multiple myeloma No suitable family donor matched
for 5 or 6 HLA antigens (A, B, DR) No suitable unrelated donor matched for 6 HLA antigens
Cord blood donor available matched for 4-6 out of 6 HLA antigens

PATIENT CHARACTERISTICS: Age: 5 to 50 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times
normal Alkaline phosphatase less than 3 times normal SGOT less than 3 times normal Renal:
Creatinine less than 2 times normal OR Creatinine clearance greater than 60 mL/min
Cardiovascular: MUGA with ejection fraction at least 50% Pulmonary: DLCO and spirometry at
least 60% OR Exercise VO2 max/kg at least 15 mL/min/kg Other: HIV antibody negative
Hepatitis B surface antigen negative No active bacterial, viral, or fungal infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed If following
limits have not been exceeded, patient may receive total body irradiation: No prior
radiation to one entire kidney Whole liver received no greater than 1000 cGy No prior whole
abdomen radiotherapy Small bowel received no greater than 3000 cGy Heart received no
greater than 1800 cGy No prior whole lung radiotherapy CNS received less than 30 cGy (whole
brain or any portion of the spine) Surgery: Not specified