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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: methotrexate
* Drug: zidovudine
* Procedure: neoadjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methotrexate|nan|
|Drug: zidovudine|nan|
|Procedure: neoadjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Toxicity |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related primary CNS lymphoma