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Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

NCT ID: NCT00032149

Last Updated: 2013-09-20

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

Detailed Description

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OBJECTIVES:

* Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
* Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Conditions

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Lymphoma

Keywords

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AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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bleomycin sulfate

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

etoposide

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

prednisolone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:

* Prior diagnosis of acquired immune deficiency syndrome (AIDS)
* CD4 count \< 100,000/mm3
* ECOG performance status \> 2

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* See Disease Characteristics

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic:

* Not specified

Chemotherapy:

* Not specified

Endocrine:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lymphoma Trials Office

OTHER

Sponsor Role lead

Principal Investigators

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Ruth Pettengell, MD

Role: STUDY_CHAIR

St George's, University of London

Locations

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Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status

St. Georges, University of London

London, England, United Kingdom

Site Status

King's College Hospital

London, England, United Kingdom

Site Status

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BNLI-GOODRISKHIV

Identifier Type: -

Identifier Source: secondary_id

EU-20144

Identifier Type: -

Identifier Source: secondary_id

CDR0000069261

Identifier Type: -

Identifier Source: org_study_id