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

Sponsor

International Extranodal Lymphoma Study Group (IELSG) (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00210340

Collaborator

(none)

Enrollment

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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

Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
Pathologically diagnosed CD20-positive NHL
Age ≥ 18 years
ECOG Performance Status 0 - 2 (See Appendix A)
Life expectancy of at least 1 month
Informed consent must be given according to national/local regulations before enrollment (See Appendix B)
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
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
No concurrent intrathecal chemotherapy other than rituximab
No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless due to proven lymphoma involvement
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
No evidence of active opportunistic infections
No HIV infection
No pregnant or lactating status
Appropriate contraceptive method in women of childbearing potential or men
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
Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.

Contacts and Locations

Locations

No locations specified.

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