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

NCT02494700 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2014-1046NCI-2015-01203
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage I Grade 1 Follicular Lymphoma; Ann Arbor Stage II Grade 2 Follicular Lymphoma; Ann Arbor Stage II Mantle Cell Lymphoma; Ann Arbor Stage III Grade 1 Follicular Lymphoma; Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV Grade 1 Follicular Lymphoma; Ocular Adnexal Lymphoma; Ann Arbor Stage I Mantle Cell Lymphoma; Ann Arbor Stage I Grade 2 Follicular Lymphoma; Ann Arbor Stage I Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage II B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage II Grade 1 Follicular Lymphoma; Ann Arbor Stage II Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage III Grade 2 Follicular Lymphoma; Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage III Mantle Cell Lymphoma; Ann Arbor Stage IV Grade 2 Follicular Lymphoma; Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage IV Mantle Cell Lymphoma; Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma; Orbit Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  Local orbital event will be estimated using the Kaplan-Meier method.

  Up to 2 years post-radiation

Secondary Outcomes (5)

• Complete response rate

  Up to 2 years

• Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field)

  Up to 2 years post-radiation therapy

• Overall survival (OS)

  Up to 2 years

• Freedom from distant relapse rates

  Up to 2 years

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

  Up to 2 years

Study Arms (1)

Treatment (low dose orbital EBRT)

EXPERIMENTAL

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.

Radiation: External Beam Radiation Therapy; Drug: Orbital Radiation

Interventions

External Beam Radiation Therapy RADIATION

Undergo orbital EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation

Treatment (low dose orbital EBRT)

Orbital Radiation DRUG

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.

Also known as: XRT

Treatment (low dose orbital EBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Pinnix CC, Dabaja BS, Gunther JR, Fang PQ, Wu SY, Nastoupil LJ, Strati P, Nair R, Ahmed S, Steiner R, Westin J, Neelapu S, Rodriguez MA, Lee HJ, Wang M, Flowers C, Feng L, Esmaeli B. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1195-1203. doi: 10.1001/jamaoncol.2024.2112.

  PMID: 38990564 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Orbital lymphoma

Study Officials

• Chelsea C Pinnix, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 10, 2015
• Study Start: July 6, 2015
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)