HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
filgrastim
+ sargramostim
+ carmustine
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: March 1, 1995
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia. Determine the dose effect of autologous PBSC on engraftment in this patient population. OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells. Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation. Patients are followed at 100 days, 6 months, and 1 year. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia Pathologic evidence of relapse in marrow, CNS, or testes In second or later complete remission Ineligible for allogeneic transplantation: No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR Ineligible for preparative regimen including total-body irradiation Peripheral blood stem cell collection feasible: Patient size generally at least 8 kg Able to place central venous catheter Patient cooperative PATIENT CHARACTERISTICS: Age: 1 to 19 Performance status: Not moribund Life expectancy: No severe limits from disease other than leukemia Hepatic: Bilirubin no greater than 3 times normal for age AST and/or GGT no greater than 3 times normal for age No evidence of hepatic synthetic dysfunction Renal: GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance Cardiovascular: Cardiac contractility normal on echocardiogram Pulmonary: FVC and FEV_1 with or without DLCO at least 50% predicted Other: No significant active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Nebraska Medical Center
Omaha, United StatesOpen University of Nebraska Medical Center in Google Maps