Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
Primary Purpose
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
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
External Beam Radiation Therapy
Orbital Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients with stage I-IV indolent B cell lymphoma, including mucosa-associated lymphoid tissue (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
- Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma
- 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
- Female patients of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
- 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
- Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
- 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)
- Patients must have the ability to give informed consent
Exclusion Criteria:
- Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan)
- Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
- Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
- Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
- Patients with pre-existing retinopathy
- Patients who are pregnant
- Patients with active lupus or scleroderma are ineligible
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (low dose orbital EBRT)
Arm Description
Patients undergo two fractions of low dose orbital 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.
Outcomes
Primary Outcome Measures
Local orbital control (i.e. local control within the radiation field)
Local orbital event will be estimated using the Kaplan-Meier method.
Secondary Outcome Measures
Complete response rate
Response rate will be estimated along with 95% confidence intervals.
Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field)
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method.
Freedom from distant relapse rates
Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Toxicity data will be summarized by frequency tables.
Full Information
NCT ID
NCT02494700
First Posted
July 8, 2015
Last Updated
May 25, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02494700
Brief Title
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
Official Title
Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2015 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (low dose orbital EBRT)
Arm Type
Experimental
Arm Description
Patients undergo two fractions of low dose orbital 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.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation
Intervention Description
Undergo orbital EBRT
Intervention Type
Drug
Intervention Name(s)
Orbital Radiation
Other Intervention Name(s)
XRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local orbital control (i.e. local control within the radiation field)
Description
Local orbital event will be estimated using the Kaplan-Meier method.
Time Frame
Up to 2 years post-radiation
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Response rate will be estimated along with 95% confidence intervals.
Time Frame
Up to 2 years
Title
Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field)
Time Frame
Up to 2 years post-radiation therapy
Title
Overall survival (OS)
Description
OS will be estimated using the Kaplan-Meier method.
Time Frame
Up to 2 years
Title
Freedom from distant relapse rates
Time Frame
Up to 2 years
Title
Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Description
Toxicity data will be summarized by frequency tables.
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stage I-IV indolent B cell lymphoma, including mucosa-associated lymphoid tissue (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
Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma
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
Female patients of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
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
Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
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)
Patients must have the ability to give informed consent
Exclusion Criteria:
Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan)
Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
Patients with pre-existing retinopathy
Patients who are pregnant
Patients with active lupus or scleroderma are ineligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chelsea C Pinnix
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
We'll reach out to this number within 24 hrs