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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003261

Enrollment

Registered

2003-01-27

Start date

1997-05-31

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

AIDS-related primary CNS lymphoma

Brief summary

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

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.

Interventions

DRUGmethotrexate

DRUGzidovudine

PROCEDUREneoadjuvant therapy

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy	—
Toxicity	—
Overall survival	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026