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

NCT00210340 | Withdrawn Phase 1

• 1 other identifier: IELSG24
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma, B Cell

Outcome Measures

Primary Outcomes (1)

• Safety profile of rituximab given intrathecally

Secondary Outcomes (3)

• 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

Interventions

intrathecal rituximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Related Links

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

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Last Updated: March 30, 2015

Record last verified: 2015-03