Houston, Texas 77030


Purpose:

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.


Study 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bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.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biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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 row. Contrast drugs allow researchers to see the difference between normal and abnormal tissue. Follow Up Visits: Every 3 months: - You will have an eye exam by an eye doctor. - You will have an MRI or CT scan to check the status of the disease. If the study doctor thinks it is needed, you will receive the standard dose of radiation at that time. In that case, you will sign a separate consent that explains the risks. Length of Study Participation: You may continue taking part in the study as long as the study doctor thinks it is in your best interest. You will no longer be able to take part if intolerable side effects occur or if you are unable to follow study directions. Your active participation on the study will be over after the follow-up visits. This is an investigational study. It is investigational to treat B cell lymphoma or mantle cell lymphoma involving the eye with lower doses of radiation. Radiation therapy given in this study is performed using FDA-approved and commercially available methods. Up to 24 participants will be enrolled on this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. 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 2. Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma 3. 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. 4. Female patients of childbearing potential must have a negative serum pregnancy test (beta-hCG) within 2 weeks of protocol entry. 5. 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. 6. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study 7. 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). 8. Patients must have the ability to give informed consent. Exclusion Criteria: 1. Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan). 2. Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma. 3. Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) 4. Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance 5. Patients with pre-existing retinopathy 6. Patients who are pregnant 7. Patients with active lupus or scleroderma are ineligible


NCT ID:

NCT02494700


Primary Contact:

Principal Investigator
Chelsea C. Pinnix, MD, PHD
M.D. Anderson Cancer Center

Chelsea C. Pinnix, MD, PHD
Phone: 713-563-2300


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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