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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: The goal of this clinical research study is to learn about the effectiveness of low dose radiation therapy in patients with low grade B cell lymphoma or mantle cell lymphoma involving the eye.

Detailed Summary:

Baseline Tests:

If you agree to take part in this study, the following baseline tests and procedures will be performed:

  • You will have a physical exam.
  • Blood (about 2 teaspoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test if you can become pregnant. To take part in this study, you cannot be pregnant.
  • You will have a computed tomography (CT) scan and a positron emission tomography (PET) scan of the head and neck to check the status of the disease. If the study doctor thinks it is needed, you may also have a magnetic resonance imaging (MRI) scan.
  • You will have a biopsy of your eye lesion. You will be given either general or local anesthesia with sedation as needed to numb the area.
  • You will have an eye exam by an eye doctor. This eye exam may include photographs being taken of your eyes.
  • If the study doctor thinks it is needed, you will have a bone marrow aspirate/biopsy to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. To collect a bone marrow biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

Study Visits:

You will have a CT scan without contrast for the purpose of planning your radiation. This is called a "CT simulation." After you complete CT simulation, you will receive low dose radiation with contrast 2 days in a ro
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Local Orbital Control [ Time Frame: 12 weeks ]

Local orbital control monitored using the method of Thall et al. Monitoring rules for time to local orbital control applied continuously with the probability criterion recomputed based on the most recent data available at that time.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 8, 2015
Date Started: July 6, 2015
Date Completion: July 1, 2018
Last Updated: January 20, 2017
Last Verified: January 2017