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Radiation Therapy

Orbital Radiation Therapy for Lymphoma

Phase 2

Waitlist Available

Led By Chelsea C Pinnix, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study

Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma

Must not have

Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma

Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying ultra low dose orbital radiation therapy to treat stage I-IV low grade B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye. This type of radiation therapy uses external beam radiation to destroy cancer cells and may be effective with fewer side effects.

Who is the study for?

This trial is for adults with stage I-IV indolent B-cell or mantle cell lymphoma affecting the eye area. Participants must have measurable disease, agree to use contraception if necessary, and can consent to treatment. Those with aggressive lymphoma types, prior orbital radiation exceeding safe levels, certain autoimmune diseases, or recent chemotherapy are excluded.

What is being tested?

The study tests ultra low dose external beam radiation therapy targeted at the orbit of the eye in patients with specific types of lymphoma. The goal is to see if this approach effectively treats cancer while minimizing side effects compared to higher doses.

What are the potential side effects?

Potential side effects may include irritation or damage to the skin and tissues around the eyes, dry or teary eyes, cataracts formation over time, and possible vision changes due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use contraception or abstain from sex during the study.

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My eye lymphoma is visible on scans or to doctors after a biopsy confirmed it's B cell type.

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I am using or willing to use two forms of birth control or am not able to become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic lymphocytic leukemia or small lymphocytic lymphoma.

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My lymphoma is of an aggressive type, such as DLBCL or grade 3 follicular.

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I have a pre-existing eye condition affecting my retina.

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I have had radiation to my eye area before and cannot have more without risking damage.

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I do not have active lupus or scleroderma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local orbital control (i.e. local control within the radiation field)

Secondary study objectives

Complete response rate

Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (low dose orbital EBRT)Experimental Treatment2 Interventions

Patients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External Beam Radiation Therapy

2006

Completed Phase 3

~3300

0 / 8Eligibility criteria met