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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003261
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: October 2001

November 1, 1999
September 19, 2013
May 1997
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  • Efficacy [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00003261 on ClinicalTrials.gov 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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Lymphoma
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00003261
CDR0000066153, ITA-GICAT-POS1, EU-97018
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Centro di Riferimento Oncologico - Aviano
Not Provided
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