Orbital Radiation Therapy for Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy

Disqualifiers: CLL/SLL, Aggressive B cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Orbital Radiation Therapy for Lymphoma?

Research shows that external beam radiotherapy (EBRT) is effective as a sole treatment for certain types of orbital and ocular lymphomas, specifically MALT and Follicular Primary Orbital and Ocular adnexal Lymphoma, indicating its potential effectiveness for similar conditions. ^{1 2 3 4 5}

Is Orbital Radiation Therapy safe for humans?

External Beam Radiation Therapy (EBRT), used for various conditions including lymphoma, has been studied for safety. Some patients may experience side effects like pain flare, which is a temporary increase in pain, reported in 16-41% of cases. Overall, EBRT is generally considered safe, but side effects can vary depending on the condition being treated. ^{2 4 5 6 7}

How is orbital radiation therapy different from other treatments for orbital lymphoma?

Orbital radiation therapy, specifically external beam radiation therapy (EBRT), is unique because it directly targets the lymphoma in the eye area with high-energy rays, leading to high rates of symptom improvement and remission. It is particularly effective for low-grade non-Hodgkin's lymphoma in the orbit, achieving long-term control in most cases. ^{4 8 9 10 11}

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.

Research Team

Chelsea C. Pinnix

Principal Investigator

M.D. Anderson Cancer Center

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 will receive treatment throughout my body after eye radiation, and its timing will be noted.

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.

Exclusion Criteria

I have chronic lymphocytic leukemia or small lymphocytic lymphoma.

Patients who are pregnant

I have not had chemotherapy for lymphoma in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days

2 days

Additional Radiation

Patients with stable or progressive disease after 12-16 weeks undergo additional low dose orbital EBRT over 10 fractions

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• External Beam Radiation Therapy
• Orbital Radiation

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 32 patients receiving External Beam Radiotherapy (EBRT) for bone metastases, 41% experienced a pain flare, which is defined as a significant increase in pain or analgesia intake, with a median duration of 3 days.

The incidence and duration of pain flare observed in this study align with findings from international studies, indicating that pain flare is a common side effect of EBRT for bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the incidence of pain flare in patients undergoing radiotherapy for symptomatic bone metastases. Goldfinch, R., White, N.[2018]

Brachytherapy for breast cancer was associated with a higher risk of both infectious and noninfectious adverse events compared to external beam radiation therapy (EBRT), with odds ratios of 1.21 and 2.27 respectively, indicating a significant difference in safety profiles.

Over time, the incidence of infectious complications after brachytherapy decreased, while noninfectious complications, particularly seromas, increased, suggesting improvements in technique and experience may be influencing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Toxicity Profile of Breast Brachytherapy Versus External Beam Radiation After Lumpectomy for Breast Cancer. Huo, J., Giordano, SH., Smith, BD., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Indications of external beams radiation for thyroid cancer. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Intensity modulated radiotherapy (IMRT) in bilateral retinoblastoma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

External Beam Radiation Therapy in pT4 Well-Differentiated Thyroid Cancer: A Population-Based Study of 405 Patients. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Radiation therapy for primary orbital and ocular adnexal lymphoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy of radiotherapy in the treatment of orbital pseudotumor. [2011]

6. Netherlands pubmed.ncbi.nlm.nih.gov

An investigation into the incidence of pain flare in patients undergoing radiotherapy for symptomatic bone metastases. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Contemporary Toxicity Profile of Breast Brachytherapy Versus External Beam Radiation After Lumpectomy for Breast Cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy is successful treatment for orbital lymphoma. [2022]

9. Singapore pubmed.ncbi.nlm.nih.gov

Orbital lymphoma: results of radiation therapy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of external beam radiation therapy for non-Hodgkin lymphoma in patients with prior 90Y-ibritumomab tiuxetan radioimmunotherapy. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of Low-grade Lymphoma of the Orbit. [2022]