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
18 Years
N/A
Both
Lymphoma
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Efficacy
Safety Issue:
No
Principal Investigator
Umberto Tirelli, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centro di Riferimento Oncologico - Aviano
Authority:
United States: Federal Government
Study ID:
CDR0000066153
NCT ID:
NCT00003261
Start Date:
May 1997
Completion Date:
Related Keywords:
- Lymphoma
- AIDS-related primary CNS lymphoma
- Lymphoma
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