NCT00004039

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 1998

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

December 10, 1999

Last Update Submit

August 17, 2015

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemiastage II grade 3 follicular lymphomastage II adult diffuse small cleaved cell lymphomastage II adult diffuse mixed cell lymphomastage II adult diffuse large cell lymphomastage II adult immunoblastic large cell lymphomastage II adult Burkitt lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult Burkitt lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Interventions

recombinant interferon alfaBIOLOGICAL
rituximabBIOLOGICAL
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
prednisoneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology At least 1 lymph node or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection or other medical condition this is lifethreatening Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma

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

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-Cell

Interventions

Interferon-alphaRituximabCyclophosphamideDoxorubicinPrednisoneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Robert O. Dillman, MD, FACP

    Cancer Biotherapy Research Group

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

August 5, 2004

Study Start

June 1, 1998

Primary Completion

January 1, 2000

Study Completion

January 1, 2000

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

US(1)