Lymphoma Clinical Trial
Official title:
Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
die. Peripheral stem cell transplantation may allow doctors to give higher doses of
chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy
plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma
or acute lymphoblastic leukemia.
OBJECTIVES: I. Determine the toxicity of an intensive induction regimen comprised of
etoposide with cyclophosphamide and total body irradiation (TBI) in patients with high grade
lymphoma or acute lymphoblastic leukemia (ALL). II. Determine the maximum tolerated dose of
etoposide when combined with cyclophosphamide and TBI in these patients. III. Determine the
response rate in patients treated with this induction regimen. IV. Determine the potential
for long term survival in patients with relapsed lymphoblastic lymphoma and chemotherapy
responsiveness treated with this induction regimen. V. Determine the efficacy of this
induction regimen followed by autologous peripheral blood stem cell transplantation (APBSCT)
in patients with ALL in any complete remission. VI. Determine the efficacy of this induction
regimen followed by APBSCT in patients will ALL after relapse and remission reinduction.
OUTLINE: This is a dose escalation study of etoposide. Patients undergo total body
irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 30 hours
beginning on day -5 and cyclophosphamide IV over 1 hour on day -3 (beginning 6 hours after
completion of etoposide infusion) and day -2. Peripheral blood stem cells are reinfused on
day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and
continuing until blood counts have recovered for 2 days. Cohorts of 5 patients receive
escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 3 of 5 patients experience dose limiting
toxicity. Patients are followed every month for 1 year and then every 6 months for 2.5
years.
PROJECTED ACCRUAL: A minimum of 5 patients will be accrued for this study.
;
Primary Purpose: Treatment
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