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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), October 2001

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Centro di Riferimento Oncologico - Aviano
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003261

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Drug: methotrexate Drug: zidovudine Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cancer Lymphoma Radiation Therapy

Drug Information available for: Methotrexate Zidovudine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	14
Study Start Date:	May 1997

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003261

Locations

Italy
Centro di Riferimento Oncologico - Aviano	Recruiting
Aviano, Italy, 33081
Contact: Umberto Tirelli, MD 39-043-465-9284 utirelli@cro.it

Sponsors and Collaborators

Centro di Riferimento Oncologico - Aviano

Investigators

Study Chair:

Umberto Tirelli, MD

Centro di Riferimento Oncologico - Aviano

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066153, ITA-GICAT-POS1, EU-97018
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003261 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

AIDS-related primary CNS lymphoma

Study placed in the following topic categories:

Antimetabolites
Anti-HIV Agents
Immunoproliferative Disorders
Immunologic Factors
Acquired Immunodeficiency Syndrome
Folate
Central Nervous System Lymphoma, Primary
Zidovudine
Folinic Acid
Folic Acid Antagonists
Antiviral Agents

Immunosuppressive Agents
Vitamin B9
Reverse Transcriptase Inhibitors
Folic Acid
Lymphatic Diseases
Anti-Retroviral Agents
HIV Infections
Methotrexate
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Zidovudine
Reproductive Control Agents
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abortifacient Agents
Methotrexate
Lymphoma

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Anti-HIV Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on July 02, 2009