Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
This trial is active, not recruiting.
|Treatments||methotrexate, zidovudine, neoadjuvant therapy, radiation therapy|
|Sponsor||Centro di Riferimento Oncologico - Aviano|
|Start date||May 1997|
|Trial size||14 participants|
|Trial identifier||NCT00003261, CDR0000066153, EU-97018, ITA-GICAT-POS1|
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.
Male or female participants at least 18 years old.
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
|Official title||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|
|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.|
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