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

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ClinicalTrials.gov Identifier: NCT00003261
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE May 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
  • Efficacy
  • Toxicity
  • Overall survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: methotrexate
  • Drug: zidovudine
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
14
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003261
Other Study ID Numbers  ICMJE CDR0000066153
ITA-GICAT-POS1
EU-97018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centro di Riferimento Oncologico - Aviano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
PRS Account 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