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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

October 10, 2009

Start Date ^ICMJE

May 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Efficacy [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy
Toxicity
Overall survival

Change History

Complete list of historical versions of study NCT00003261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Drug: methotrexate
Drug: zidovudine
Procedure: neoadjuvant therapy
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00003261

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066153, ITA-GICAT-POS1, EU-97018

Study Sponsor ^ICMJE

Centro di Riferimento Oncologico - Aviano

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Umberto Tirelli, MD

Centro di Riferimento Oncologico - Aviano

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP