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

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 Procedure: radiation therapy	Phase II

MedlinePlus related topics: AIDS Cancer Lymphoma

Drug Information available for: Zidovudine Methotrexate

U.S. FDA Resources

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

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

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

Study ID Numbers:	CDR0000066153, ITA-GICAT-POS1, EU-97018
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003261
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

AIDS-related primary CNS lymphoma

Study placed in the following topic categories:

Folic Acid
Lymphatic Diseases
Immunoproliferative Disorders
HIV Infections
Acquired Immunodeficiency Syndrome

Methotrexate
Zidovudine
Lymphoproliferative Disorders
Lymphoma
Central nervous system lymphoma, primary

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 14, 2009