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

This study has been withdrawn prior to enrollment.
(lack of accrual)
Sponsor:
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210340
First received: September 13, 2005
Last updated: January 19, 2011
Last verified: January 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

Resource links provided by NLM:


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

  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
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: NCT00210340

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00210340     History of Changes
Other Study ID Numbers: IELSG24
Study First Received: September 13, 2005
Last Updated: January 19, 2011
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on July 24, 2014