Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkin's lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H)|
- Pharmacodynamics of etoposide [ Time Frame: days 8, 15, and 22 of tx ] [ Designated as safety issue: Yes ]
- Response [ Time Frame: Day 1 of ea cycle, then q 6 mon/2 yrs then yearly until death or ds progression ] [ Designated as safety issue: No ]
|Study Start Date:||November 1996|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Oral etoposide for relapsed or refractory non-Hodgkin's lymphoma
Drug: Etoposide phosphate
50 mg PO q day for 21 days; repeat every 28 days escalate dose to 100 mg PO q day if ANC remains greater than 1500/microliter during cycle 1: no specified maximum of cycles if PR or CR
OBJECTIVES: I. Evaluate the response rate and response duration in patients with relapsed non-Hodgkin's lymphoma when treated with daily oral etoposide. II. Describe the toxic effects of daily oral etoposide in these patients. III. Monitor etoposide trough levels and determine whether etoposide concentrations correlate with age, response, and toxicity.
OUTLINE: Patients receive oral etoposide daily for 21 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients in complete or partial remission receive 2 courses past best response (minimum 6 courses). Patients with stable disease after 3 courses may be removed from study. Patients are followed every 6 months for 2 years, then annually for survival.
PROJECTED ACCRUAL: Approximately 97 patients will be accrued for this study over 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002880
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington University Barnard Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|St. Joseph's Hospital and Medical Center|
|Paterson, New Jersey, United States, 07503|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Nancy L. Bartlett, MD||Washington University Siteman Cancer Center|