Orbital Radiation Therapy for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach for treating low-grade B-cell lymphoma or mantle cell lymphoma in the eye area using ultra low dose orbital radiation therapy, a form of external beam radiation therapy. The goal is to determine if this method can effectively destroy cancer cells while causing fewer side effects. It is an option for those diagnosed with these specific types of lymphoma affecting the eye. Participants should not have had recent chemotherapy and must not have aggressive forms of B-cell lymphoma.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have been treated with chemotherapy for lymphoma within 4 weeks before joining the trial, you would not be eligible to participate.
What prior data suggests that orbital radiation therapy is safe for treating lymphoma?
Research has shown that low-dose external beam radiation therapy (EBRT) is well-tolerated for treating low-grade lymphoma in the eye. Studies have found that this treatment effectively controls cancer with few side effects. In one study, EBRT for eye lymphomas resulted in no cancer recurrence in the treated area. Another study confirmed that ultra-low-dose radiation therapy effectively manages cancer in the eye area.
Patients in these studies did not report any major negative side effects from EBRT, suggesting the treatment is generally safe for people with this type of lymphoma. Since this trial is in Phase 2, earlier studies have already demonstrated some safety, but researchers continue to collect more data to ensure it is safe and effective for more patients.12345Why do researchers think this study treatment might be promising?
Researchers are excited about low dose orbital External Beam Radiation Therapy (EBRT) for lymphoma because it offers a targeted approach that could potentially minimize side effects compared to traditional, more widespread radiation treatments. Unlike standard treatments, which often involve higher doses of radiation that can affect surrounding healthy tissue, this low dose approach aims to effectively target the orbital area with precision. Additionally, the flexibility of administering additional fractions based on patient response could provide a more personalized treatment strategy, potentially improving outcomes for patients with stable or progressive disease.
What evidence suggests that ultra low dose orbital radiation therapy is effective for treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye?
Research has shown that very low doses of radiation can effectively treat slow-growing B-cell lymphoma around the eye. In this trial, participants will receive low-dose orbital External Beam Radiation Therapy (EBRT). Studies have found that this therapy can stop or slow cancer growth in the treated area and has low recurrence rates, reducing the likelihood of cancer returning after treatment. Importantly, this therapy preserves eye function, which is crucial for treatments in this sensitive area. Overall, evidence supports the effectiveness of this radiation therapy in managing lymphoma near the eye.13678
Who Is on the Research Team?
Chelsea C. Pinnix
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days
Additional Radiation
Patients with stable or progressive disease after 12-16 weeks undergo additional low dose orbital EBRT over 10 fractions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- External Beam Radiation Therapy
- Orbital Radiation
External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator