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bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.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biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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 ]
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