This trial is active, not recruiting.

Condition lymphoma
Treatments methotrexate, zidovudine, neoadjuvant therapy, radiation therapy
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

time frame:
time frame:
Overall survival
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).