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

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ClinicalTrials.gov Identifier: NCT02494700
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Radiation: External Beam Radiation Therapy Drug: Orbital Radiation Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
Actual Study Start Date : July 6, 2015
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021


Arm Intervention/treatment
Experimental: Treatment (low dose orbital EBRT)
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.
Radiation: External Beam Radiation Therapy
Undergo orbital EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

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.
Other Name: XRT




Primary Outcome Measures :
  1. Local orbital control (i.e. local control within the radiation field) [ Time Frame: Up to 2 years post-radiation ]
    Local orbital event will be estimated using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Complete response rate [ Time Frame: Up to 2 years ]
    Response rate will be estimated along with 95% confidence intervals.

  2. 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 ]
  3. Overall survival (OS) [ Time Frame: Up to 2 years ]
    OS will be estimated using the Kaplan-Meier method.

  4. Freedom from distant relapse rates [ Time Frame: Up to 2 years ]
  5. Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 2 years ]
    Toxicity data will be summarized by frequency tables.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494700


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Chelsea C. Pinnix    713-563-2300      
Principal Investigator: Chelsea C. Pinnix         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chelsea C Pinnix M.D. Anderson Cancer Center

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02494700     History of Changes
Other Study ID Numbers: 2014-1046
NCI-2015-01203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-1046 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases