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Status unknownNCT00003261Updated Sep 20, 2013

Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

A Phase 2 interventional study of methotrexate and zidovudine in Lymphoma, sponsored by Centro di Riferimento Oncologico - Aviano. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by Centro di Riferimento Oncologico - Aviano · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
14
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Lymphoma

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Keywords

  • AIDS-related primary CNS lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 14 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Centro di Riferimento Oncologico - Aviano is the lead sponsor of 47 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
14 participants (estimated)

Interventions

  • Drugmethotrexate
  • Drugzidovudine
  • Procedureneoadjuvant therapy
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Efficacy

  2. Toxicity

  3. Overall survival

07

Study locations

1 site
  • Centro di Riferimento Oncologico - Aviano
    Aviano, 33081, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003261
Lead sponsor
Centro di Riferimento Oncologico - Aviano
First posted
Jan 27, 2003
Start date
May 1997
Last update
Sep 20, 2013

Study contacts

Umberto Tirelli, MD
study chair · Centro di Riferimento Oncologico - Aviano
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2001. You cannot join it, but the record below documents what was studied.

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