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A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

This study is currently recruiting participants.
Verified by International Extranodal Lymphoma Study Group (IELSG), September 2005

Sponsored by: International Extranodal Lymphoma Study Group (IELSG)
Information provided by: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00210340
  Purpose

The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin’s lymphomas.


Condition Intervention Phase
Lymphoma, B Cell
Drug: intrathecal rituximab
Phase I

MedlinePlus related topics:   Lymphoma    Meningitis   

ChemIDplus related topics:   Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • Safety profile of rituximab given intrathecally

Secondary Outcome Measures:
  • preliminary evaluation of the antitumor activity of i.t. rituximab
  • collection of CSF samples devoted to ancillary biological studies
  • pharmacokinetics of different dose levels of intrathecal rituximab

Estimated Enrollment:   9
Study Start Date:   June 2004

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

Criteria

Inclusion Criteria:

  1. Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
  2. Pathologically diagnosed CD20-positive NHL
  3. Age ≥ 18 years
  4. ECOG Performance Status 0 - 2 (See Appendix A)
  5. Life expectancy of at least 1 month
  6. Informed consent must be given according to national/local regulations before enrollment (See Appendix B)
  7. Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or thiotepa for treatment of lymphomatous meningitis but these treatments must have completed at least two weeks before the study enrollment and the patients must have recovered from any reversible toxicity caused by prior treatments
  8. Concurrent systemic chemotherapy is allowed with the exception of high-dose methotrexate (>500 mg/m2/day), high-dose cytarabine (>2 g/m2/day), high-dose thiotepa (>300 mg/m2/day) or investigational agents
  9. No concurrent intrathecal chemotherapy other than rituximab
  10. No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless due to proven lymphoma involvement
  11. No major impairment of renal function (serum creatinine < 1,5 x upper normal) or liver function (ASAT/ALAT < 2,5 upper normal, total bilirubin <2,5x upper normal), unless due to proven lymphoma involvement
  12. No evidence of active opportunistic infections
  13. No HIV infection
  14. No pregnant or lactating status
  15. Appropriate contraceptive method in women of childbearing potential or men
  16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  17. Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210340

Contacts
Contact: Cristina Morinini     +41 91 8119040     ielsg@ticino.com    

Locations
Switzerland
Oncology Institute of Southern Switzerland (IOSI)     Recruiting
      Bellinzona, Switzerland, 6500
      Contact: Cristina Morinini     +41 91 8119040     ielsg@ticino.com    

Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)

Investigators
Study Chair:     Annarita Conconi, MD     International Extranodal Lymphoma Study Group/Hematology Division. University Amedeo Avogadro. Novara    
Study Chair:     Andres JM Ferreri, MD     Radiochemotherapy San Raffaele Hospital. Milan    
  More Information


Click here for more information about this study: phase I study of intrathecal rituximab in patients with lymphomatous meningitis  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   IELSG24
First Received:   September 13, 2005
Last Updated:   September 13, 2005
ClinicalTrials.gov Identifier:   NCT00210340
Health Authority:   Switzerland: Swissmedic

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Central Nervous System Infections
Rituximab
B-cell lymphomas
Central Nervous System Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Meningitis

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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