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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003261
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
September 20, 2013
May 1997
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  • Efficacy
  • Toxicity
  • Overall survival
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Complete list of historical versions of study NCT00003261 on Archive Site
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Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
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

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Drug: methotrexate
  • Drug: zidovudine
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
  • No systemic lymphoma



  • 18 and over

Performance status:

  • WHO 0-3

Life expectancy:

  • Not specified


  • WBC at least 3000/mm^3
  • Platelet count at least 80,000/mm^3


  • No serious impairment of liver function


  • No serious impairment of renal function
  • Creatinine clearance at least 40 mL/min


  • No serious impairment of cardiac function


  • Neurological functional status 0-3


  • No prior or active CNS-opportunistic infections
  • No AIDS dementia complex
  • No active systemic infections


  • No prior chemotherapy or radiotherapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Centro di Riferimento Oncologico - Aviano
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Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
National Cancer Institute (NCI)
October 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP