B-Cell Non-Hodgkin Lymphoma > External Beam Radiation Therapy

Orbital Radiation Therapy for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen By Chelsea C. Pinnix

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have chronic lymphocytic leukemia or small lymphocytic lymphoma.

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

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

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

I do not have active lupus or scleroderma.

Participant Groups

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.

Group I: Treatment (low dose orbital EBRT) Experimental Treatment 2 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.

External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

🇺🇸 Approved in United States as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

🇨🇦 Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

🇯🇵 Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

🇨🇳 Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

🇨🇭 Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Find A Clinic Near You

Research locations nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who is running the clinical trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References