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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2001 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 1, 1999. Last Updated on October 10, 2009 History of Changes

Sponsor:	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:	Primary Purpose: 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: Cancer HIV/AIDS Lymphoma

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
Aviano, Italy, 33081

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

ClinicalTrials.gov Identifier:	NCT00003261 History of Changes
Other Study ID Numbers:	CDR0000066153, ITA-GICAT-POS1, EU-97018
Study First Received:	November 1, 1999
Last Updated:	October 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

AIDS-related primary CNS lymphoma

Additional relevant MeSH terms:

Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Zidovudine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012