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

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

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Chelsea C Pinnix, M D · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-06

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States

Study Locations