NCT00003261

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.

Trial Health

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Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 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
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

October 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Lymphoma

Keywords

AIDS-related primary CNS lymphoma

Outcome Measures

Primary Outcomes (3)

  • Efficacy

  • Toxicity

  • Overall survival

Interventions

methotrexateDRUG
zidovudineDRUG
neoadjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS * No systemic lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-3 Life expectancy: * Not specified Hematopoietic: * WBC at least 3000/mm\^3 * Platelet count at least 80,000/mm\^3 Hepatic: * No serious impairment of liver function Renal: * No serious impairment of renal function * Creatinine clearance at least 40 mL/min Cardiovascular: * No serious impairment of cardiac function Neurologic: * Neurological functional status 0-3 Other: * No prior or active CNS-opportunistic infections * No AIDS dementia complex * No active systemic infections PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy

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

MeSH Terms

Conditions

Lymphoma

Interventions

MethotrexateZidovudineNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCombined Modality TherapyTherapeutics

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

January 27, 2003

Study Start

May 1, 1997

Last Updated

September 20, 2013

Record last verified: 2001-10

Locations

IT(1)