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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003261
• Other study ID #: CDR0000066153
• Secondary ID: ITA-GICAT-POS1EU
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: May 1997

Study information

• Verified date: October 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• methotrexate

• zidovudine

Procedure:
• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Aviano	Aviano

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No
Primary	Toxicity			Yes
Primary	Overall survival			No