NCT00003262

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

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

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 23, 2003

Completed
Last Updated

September 20, 2013

Status Verified

October 1, 2002

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaAIDS-related peripheral/systemic lymphomaHIV-associated Hodgkin lymphoma

Interventions

bleomycin sulfateBIOLOGICAL
filgrastimBIOLOGICAL
Stanford V regimenDRUG
doxorubicin hydrochlorideDRUG
epirubicin hydrochlorideDRUG
etoposideDRUG
mechlorethamine hydrochlorideDRUG
prednisoneDRUG
vinblastine sulfateDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven Hodgkin's disease: * Clinical or pathologic stage II - IV * Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms * Confirmed HIV infection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-4 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No severe cardiac disease Pulmonary: * No severe pulmonary disease Other: * No severe neurologic or metabolic disease * No concurrent or prior second malignancy except: * Nonmelanomatous skin cancer * In situ cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for Hodgkin's disease * Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required

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

Sponsors & Collaborators

Study Sites (1)

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Related Publications (1)

  • Spina M, Gabarre J, Rossi G, Fasan M, Schiantarelli C, Nigra E, Mena M, Antinori A, Ammassari A, Talamini R, Vaccher E, di Gennaro G, Tirelli U. Stanford V regimen and concomitant HAART in 59 patients with Hodgkin disease and HIV infection. Blood. 2002 Sep 15;100(6):1984-8. doi: 10.1182/blood-2002-03-0989.

    PMID: 12200356BACKGROUND

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

BleomycinFilgrastimDoxorubicinEpirubicinEtoposideMechlorethaminePrednisoneVinblastineVincristine

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 FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Umberto Tirelli, MD

    Centro di Riferimento Oncologico - Aviano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2003

Study Start

May 1, 1997

Last Updated

September 20, 2013

Record last verified: 2002-10

Locations

IT(1)