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Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

NCT ID: NCT00006669

Last Updated: 2021-10-27

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2000-01-31

Brief Summary

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RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.

Detailed Description

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OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+ intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxicity of the regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7, cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Conditions

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Lymphoma

Keywords

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recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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rituximab

Intervention Type BIOLOGICAL

sargramostim

Intervention Type BIOLOGICAL

EPOCH regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3\* Platelet count at least 100,000/mm3\* \*unless there is bone marrow involvement with lymphoma Hepatic: Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior rituximab
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sein Aung, MD

Role: STUDY_CHAIR

Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Locations

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Washington Cancer Institute

Washington D.C., District of Columbia, United States

Site Status

Franklin Square Hospital Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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WHC-99365

Identifier Type: -

Identifier Source: secondary_id

NCI-V00-1630

Identifier Type: -

Identifier Source: secondary_id

CDR0000068283

Identifier Type: -

Identifier Source: org_study_id