NCT00032149

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 lymphoma

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

March 1, 2007

First QC Date

March 8, 2002

Last Update Submit

September 19, 2013

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Toxicity

  • Effects of treatment on response rate, time to disease progression, and survival

Interventions

bleomycin sulfateBIOLOGICAL
filgrastimBIOLOGICAL
cyclophosphamideDRUG
etoposideDRUG
mitoxantrone hydrochlorideDRUG
prednisoloneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

Location

King's College Hospital

London, England, W1T 4TJ, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma

Interventions

BleomycinFilgrastimCyclophosphamideEtoposideMitoxantronePrednisoloneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesAnthraquinonesAnthronesAnthracenesQuinonesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Ruth Pettengell, MD

    St George's, University of London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Last Updated

September 20, 2013

Record last verified: 2007-03

Locations

GB(4)