Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
NCT ID: NCT00003261
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
14 participants
INTERVENTIONAL
1997-05-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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methotrexate
zidovudine
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centro di Riferimento Oncologico - Aviano
OTHER
Principal Investigators
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Umberto Tirelli, MD
Role: STUDY_CHAIR
Centro di Riferimento Oncologico - Aviano
Locations
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Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Countries
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Other Identifiers
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ITA-GICAT-POS1
Identifier Type: -
Identifier Source: secondary_id
EU-97018
Identifier Type: -
Identifier Source: secondary_id
CDR0000066153
Identifier Type: -
Identifier Source: org_study_id