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Completed

NCT Number: NCT00002880

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically documented non-Hodgkin's lymphoma Needle or core biopsy not acceptable as sole means of diagnosis No mantle cell or transformed lymphoma One of the following International Working Formulation (IWF) histologic subtypes required: Small lymphocytic with absolute lymphocytic count less than 5,000 (IWF A) Follicular, predominately small cleaved cell (IWF B) Follicular, mixed (IWF C) Follicular, large cell (IWF D) Diffuse, small cleaved cell (IWF E) Diffuse, mixed (IWF F) Diffuse, large cell (IWF G) Large cell, immunoblastic (IWF H) Recurrent or refractory disease treated with no more than 4 prior chemotherapy regimens Rebiopsy of a node at first relapse recommended Prior etoposide (oral or intravenous) allowed if given for no more than 5 days every 3 weeks The following are considered 1 prior therapy each: Identical drugs given on 2 different schedules Bone marrow transplant preparative regimen (single cycle of chemotherapy used solely to mobilize peripheral blood stem cells considered part of preparative regimen) Ineligible for protocol CLB-9551 (aminocamptothecin) Measurable disease by physical exam or imaging study required Indicator lesion larger than 1 x 1 cm No prior radiotherapy to indicator lesion unless progression clearly documented The following are not considered measurable: Barium study Ascites or pleural effusions Bony disease Bone marrow involvement No known parenchymal or leptomeningeal CNS disease Lumbar puncture not required prior to study

PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: HIV negative (testing required for patients at risk) No uncontrolled infection No other serious medical condition that would interfere with evaluation of study agent No psychiatric condition that would preclude protocol completion or informed consent No second malignancy within 5 years except curatively treated: Basal cell skin cancer Cervical cancer Not pregnant or nursing Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (3 weeks for nitrosoureas, melphalan, or mitomycin) Endocrine therapy: No concurrent corticosteroids except for physiologic replacement Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agent

Treatment and study plan

Etoposide Phosphate

Drug

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

Primary outcomes

  1. Pharmacodynamics of etoposide

    Time frame: days 8, 15, and 22 of tx

Secondary outcomes

  1. Response

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

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H)

Important dates

Study start
1996
Primary completion
2001
Study completion
2008
First posted
May 21, 2004
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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