Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: Etoposide phosphate

• Registration Number: NCT00002880
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1996-11
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study First Submitted QC: 2004-05-20
• Study First Posted: 2004-05-21
• Study Completion: 2008-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etoposide	Etoposide phosphate	Oral etoposide for relapsed or refractory non-Hodgkin's lymphoma

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics of etoposide	days 8, 15, and 22 of tx

Secondary Outcome Measures

Name	Time	Method
Response	Day 1 of ea cycle, then q 6 mon/2 yrs then yearly until death or ds progression

Trial Locations

Locations (4)

Washington University Barnard Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Paterson, New Jersey, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States