Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	ITA-GICAT-POS1 EU-97018, NCT00003261

Objectives

1. Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.
2. Evaluate the toxicity and overall survival of these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
• No systemic lymphoma

Prior/Concurrent Therapy:

• No prior chemotherapy or radiotherapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3000/mm³
• Platelet count at least 80,000/mm³

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

Expected Enrollment

This study will accrue 14 patients.

Outcomes

Efficacy
Toxicity
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Centro di Riferimento Oncologico - Aviano

Umberto Tirelli, MD, Protocol chair		Ph: 39-043-465-9284 Email: utirelli@cro.it

Registry 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
Trial Start Date		1997-05-01
Registered in ClinicalTrials.gov		NCT00003261
Date Submitted to PDQ		1997-12-09
Information Last Verified		2001-10-09

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