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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210340
Recruitment Status : Withdrawn (lack of accrual)
First Posted : September 21, 2005
Last Update Posted : March 30, 2015
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, B Cell Drug: intrathecal rituximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Meningitis
Drug Information available for: Rituximab

Primary Outcome Measures :
  1. Safety profile of rituximab given intrathecally

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210340

Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
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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

Additional Information:
Layout table for additonal information Identifier: NCT00210340     History of Changes
Other Study ID Numbers: IELSG24
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Lymphoma, B-Cell
Meningeal Carcinomatosis
Central Nervous System Diseases
Nervous System Diseases
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents