Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00004898|
Recruitment Status : Completed
First Posted : March 3, 2004
Last Update Posted : June 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|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|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004898
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Ann Traynor, MD||Robert H. Lurie Cancer Center|