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

NCT ID: NCT00002880

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etoposide

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

Group Type EXPERIMENTAL

Etoposide phosphate

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Bartlett, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Locations

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University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Site Status

Washington University Barnard Cancer Center

St Louis, Missouri, United States

Site Status

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, United States

Site Status

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLB-9650

Identifier Type: -

Identifier Source: secondary_id

CDR0000065180

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-9650

Identifier Type: -

Identifier Source: org_study_id

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