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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003261
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: October 2001
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related primary CNS lymphoma

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Methotrexate
Zidovudine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014