Suspended

Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy

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What is being tested

methotrexate

+ zidovudine

+ neoadjuvant therapy

DrugProcedureRadiation
Who is being recruted

Hemic and Lymphatic Diseases+5

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1997
See protocol details

Summary

Principal SponsorCentro di Riferimento Oncologico - Aviano
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients. Evaluate the toxicity and overall survival of these patients. OUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: This study will accrue 14 patients.

NCT00003261
Principal SponsorCentro di Riferimento Oncologico - Aviano
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centro di Riferimento Oncologico - Aviano

Aviano, ItalyOpen Centro di Riferimento Oncologico - Aviano in Google Maps
SuspendedOne Study Center