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

Lymphoma, B Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00210340
• Other study ID #: IELSG24
• Status: Withdrawn
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: March 27, 2015

Study information

• Verified date: March 2015
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, B Cell
• Lymphoma, B-Cell
• Meningeal Carcinomatosis
• Meningitis

Intervention

Drug:
• intrathecal rituximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of rituximab given intrathecally
Secondary	preliminary evaluation of the antitumor activity of i.t. rituximab
Secondary	collection of CSF samples devoted to ancillary biological studies
Secondary	pharmacokinetics of different dose levels of intrathecal rituximab

External Links

•   Click here for more information about this study: phase I study of intrathecal rituximab in patients with lymphomatous meningitis