Trials / Active Not Recruiting

Active Not RecruitingNCT02494700

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

Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 50 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of ultra low dose 4 Gray (Gy) orbital radiation, measured as local orbital control (i.e. local control within the radiation field), in patients with limited and advanced stage low grade B lymphocyte (B cell) lymphoma and mantle cell lymphoma involving the ocular adnexa. II. To evaluate the efficacy of ultra low dose 4 Gy orbital radiation, measured as complete response, in patients with limited and advanced stage low grade B cell lymphoma and mantle cell lymphoma involving the ocular adnexa. III. To evaluate the acute and chronic toxicity of radiation to the orbit. SECONDARY OBJECTIVE: I. To determine if dynamic contrast enhanced magnetic resonance imaging can predict response to ultra low dose radiation therapy. OUTLINE: Patients undergo low dose orbital external beam radiation therapy (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. After completion of study treatment, patients are followed up every 3-4 months for 6-8 months, every 6-12 months for up to 2 years, and then periodically thereafter.

Conditions

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo orbital EBRT
DRUG	Orbital Radiation	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.

Timeline

Start date: 2015-07-06
Primary completion: 2027-06-30
Completion: 2027-06-30
First posted: 2015-07-10
Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02494700. Inclusion in this directory is not an endorsement.