Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
Recruitment status was Active, not recruiting
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.
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|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|
- Efficacy [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||May 1997|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003261
|Centro di Riferimento Oncologico - Aviano|
|Aviano, Italy, 33081|
|Study Chair:||Umberto Tirelli, MD||Centro di Riferimento Oncologico - Aviano|