Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002880|
Recruitment Status : Completed
First Posted : May 21, 2004
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Etoposide phosphate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H)|
|Study Start Date :||November 1996|
|Actual Primary Completion Date :||January 2001|
|Actual Study Completion Date :||January 2008|
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
- Pharmacodynamics of etoposide [ Time Frame: days 8, 15, and 22 of tx ]
- Response [ Time Frame: Day 1 of ea cycle, then q 6 mon/2 yrs then yearly until death or ds progression ]
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): 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 Bartlett, MD||Washington University Siteman Cancer Center|