Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT02494700

PHASE2

Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.

Official title: Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2015-07-06

Completion Date

2027-06-30

Last Updated

2026-01-07

Healthy Volunteers

Conditions

Interventions

RADIATION

External Beam Radiation Therapy

Undergo orbital EBRT

DRUG

Orbital Radiation

Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.

Inclusion Criteria: * Patients 18 years or older with stage I-IV indolent B cell lymphoma, including MALT and follicular grade I/II. Patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent B cell lymphoma. Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible. * Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma. * Bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived. * Female patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 2 weeks of protocol entry. * Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy. * Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study. * Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses \> two years or surgically sterilized). * Patients must have the ability to give informed consent. Exclusion Criteria: * Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan). * Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma. * Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). * Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance. * Patients with pre-existing retinopathy. * Patients who are pregnant. * Patients with active lupus or scleroderma are ineligible

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States