Completed

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

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What is being tested

Etoposide phosphate

Drug
Who is being recruted

Blood Protein Disorders+27

+ Cardiovascular Diseases

+ Chronic Disease

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1996
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: June 28, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00002880
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: June 28, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesLeukemia, B-CellLymphoma, B-CellHemostatic DisordersDisease AttributesNeoplasms, Plasma CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, Diffuse

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Oral etoposide for relapsed or refractory non-Hodgkin's lymphoma

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

University of Minnesota Cancer Center

Minneapolis, United StatesOpen University of Minnesota Cancer Center in Google Maps

Washington University Barnard Cancer Center

St Louis, United States

St. Joseph's Hospital and Medical Center

Paterson, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, United States
Completed4 Study Centers