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Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma

NCT00387023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-11-18

Study results available
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Summary

Primary Objectives:

1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
2. To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.

Conditions

Interventions

DRUG

Rituximab

250 mg/m\^2 IV over 4-6 hours for 2 weeks.

DRUG

Zevalin

5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Bita Esmaeli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387023 on ClinicalTrials.gov