Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Lymphoma, Orthopedic, Hematology, Hematology, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 5 - 50 |
| Updated: | 10/28/2017 |
| Start Date: | September 4, 1997 |
| End Date: | October 16, 2017 |
Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes
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.
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.
OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source
for stem cell transplantation in patients with hematologic malignancies.
OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell
collection prior to transplant regimen, unless the patient has acute leukemia in relapse,
aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body
irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then
undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG)
IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not
eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of
16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All
patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and
filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly
for 2 years.
PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this
study within 4 years.
for stem cell transplantation in patients with hematologic malignancies.
OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell
collection prior to transplant regimen, unless the patient has acute leukemia in relapse,
aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body
irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then
undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG)
IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not
eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of
16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All
patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and
filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly
for 2 years.
PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this
study within 4 years.
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
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