NCT00416923

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

December 27, 2006

Last Update Submit

February 12, 2015

Conditions

Brain and Central Nervous System TumorsLymphoma

Keywords

recurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomaprimary central nervous system non-Hodgkin lymphomaleptomeningeal metastasesintraocular lymphomaAIDS-related primary CNS lymphomaWaldenström macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (3)

  • Adverse events as a measure of safety of intrathecal administration of Rituximab

    up to 5 years after completion of 5 week study treatment

  • Serum concentration of Rituximab

    during 5 weeks of study treatment

  • Cerebrospinal Fluid (CSF) concentration of Rituximab

    during 5 weeks of study treatment

Study Arms (1)

intrathecal rituximab

EXPERIMENTAL

3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg

Biological: rituximab

Interventions

rituximabBIOLOGICAL
intrathecal rituximab

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Cytologically confirmed relapsed CNS lymphoma * Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma * Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy * Tumors must be CD20+ on pathologic analysis * Refractory or persistent disease allowed * No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy * No obstructive hydrocephalus PATIENT CHARACTERISTICS: * Karnofsky performance status \> 50% * Must have an Ommaya reservoir * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 50,000/mm\^3 * Anticipated survival ≥ 1 month PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from toxicity of prior therapy * Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed * Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents * No history of whole-brain or craniospinal radiation \< 1 week before study entry * No history of intrathecal chemotherapy \< 1 week before study entry * No concurrent intrathecal chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Rubenstein JL, Fridlyand J, Abrey L, Shen A, Karch J, Wang E, Issa S, Damon L, Prados M, McDermott M, O'Brien J, Haqq C, Shuman M. Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1350-6. doi: 10.1200/JCO.2006.09.7311. Epub 2007 Feb 20.

    PMID: 17312328RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellMeningeal CarcinomatosisIntraocular LymphomaWaldenstrom Macroglobulinemia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMeningeal NeoplasmsEye NeoplasmsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • James L. Rubenstein, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

August 1, 2002

Primary Completion

November 1, 2005

Study Completion

April 1, 2007

Last Updated

February 16, 2015

Record last verified: 2015-02