Radiation - Dose Level 0 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago, Chicago, IL
Lymphoma+3 More
Radiation - Dose Level 0 - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma

See full description

Eligible Conditions

  • Lymphoma
  • Non-hodgkin Lymphoma
  • Lymphoma, Hodgkins

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Radiation - Dose Level 0 will improve 1 primary outcome and 6 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 1 Month.

1 Month
Maximum Tolerated Dose Per Fraction of Radiation
Rate of Reported Adverse Events Within 1 Month of Radiation
Year 2
Local Control of Treated Lesions After Radiation Treatment
Overall Response Rate to Radiation Treatment
Overall Survival After Radiation Treatment
Progression-Free Survival of Participants After Radiation Treatment
Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation

Trial Safety

Trial Design

5 Treatment Groups

Dose-Finding Group 3 - Dose Level 3
1 of 5
Dose-Finding Group 4 - Dose Level 4
1 of 5
Dose-Finding Group 0 - Dose Level 0
1 of 5
Dose-Finding Group 2 - Dose Level 2
1 of 5
Dose-Finding Group 1 - Dose Level 1
1 of 5
Experimental Treatment

This trial requires 30 total participants across 5 different treatment groups

This trial involves 5 different treatments. Radiation - Dose Level 0 is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Dose-Finding Group 3 - Dose Level 3
Radiation
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Dose-Finding Group 4 - Dose Level 4
Radiation
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Dose-Finding Group 0 - Dose Level 0
Radiation
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Dose-Finding Group 2 - Dose Level 2
Radiation
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Dose-Finding Group 1 - Dose Level 1
Radiation
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after last dose of radiation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years after last dose of radiation for reporting.

Closest Location

University of Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The individual must have a clinically confirmed relapse or refractory Hodgkin or non-Hodgkin lymphoma. show original
In order to participate in this study, you must be willing and able to comply with the study requirements, which include scheduled visits, treatment, laboratory testing, etc. show original
Participants must be able to give self-consent and then sign and date an IRB/Independent Ethics Committee (IEC)-approved written informed consent in accordance with local regulatory and institutional guidelines show original
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
People who are 18 years or older. show original
Mushrooms have been treated with the appropriate standard of care treatment options (in the opinion of the treating investigator). show original
All tumors must meet RECIST 1.1 criteria, including one that is measureable and 5 cm or larger show original
Must have at least one functioning organ as determined by clinical lab values provided to the study doctor. show original
Must have a life expectancy of at least one month as determined by a doctor. show original
Women of childbearing potential must have a negative pregnancy test within 72 hours prior to the start of the study. show original

Patient Q&A Section

Is radiation - dose level 0 typically used in combination with any other treatments?

"Data from a recent study of this study indicate that RT-dose levels 0 and ≥ 2 Gy can be administered safely together with other treatments. The good quality of life and excellent survival rate warrant further investigations regarding optimal radiation-dose level using IMRT as well as new methods for early determination of organ toxicity during radiotherapy." - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"A cure can be achieved only for certain types of lymphoma, such as non-Hodgkin's lymphoma. It is possible to cure a person with Hodgkin's disease from the disease, but there is no guarantee that the person will remain free of the disease indefinitely. However, some recent studies suggest that Hodgkin's disease may become more manageable over time (i.e., after a period of initial remission). Also, a cure cannot be guaranteed for patients with mantle cell lymphoma, Burkitt's lymphoma, diffuse large B-cell lymphoma, or chronic lymphocytic leukemia." - Anonymous Online Contributor

Unverified Answer

How does radiation - dose level 0 work?

"Radiation therapy restores tumor destruction in patients with HL, regardless of the stage. In addition, the improvement in tumor control caused by radiation therapy was not associated with significant changes in overall survival or relapse-free survival." - Anonymous Online Contributor

Unverified Answer

What does radiation - dose level 0 usually treat?

"Radiation therapy is an effective treatment.. Radiation therapy has improved survival over the past 15 years. A definitive link between radiotherapy and HL could not be established. Overall incidence rates of HL have decreased by 42% since 1992." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"A significant number of patients with lymphoma or at risk of developing lymphoma are currently receiving insufficient amounts of timely treatment. There is also a large proportion of people who have not received any therapy for their lymphoma. New therapies continue to be discovered; however, there remains a strong need for effectiveness and safety testing before these new drugs become available to patients. It is estimated that over 90% of patients would benefit from existing therapies if they could be improved to maximize efficacy while minimizing toxic effects." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma a year in the United States?

"Approximately 730 cases per 100,000 persons a year in the U.S. are reported as having lymphoma, based primarily on data obtained from the National Cancer Institute Surveillance Epidemiology and End Results database. These estimates may underestimate the true incidence of lymphoma because they exclude undiagnosed cases and underdiagnose cases that do not produce symptoms. But this underestimation does not substantially change the estimated annual incidence. Because the incidence of lymphoma varies widely by geographic location and socioeconomic status, these estimates should help guide resource allocation in the U.S. and elsewhere." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"More recent studies have shown a correlation between improved outcomes in both localized and advanced-stage disease, as well as among specific subtypes of lymphoma. Although there may be modest differences in survival rates between racial groups, these differences are unlikely to result in disparities in survival. Results from a recent clinical trial are consistent with national data demonstrating that overall survival in lymphoma patients is improving steadily." - Anonymous Online Contributor

Unverified Answer

What is radiation - dose level 0?

"The radiation dose levels prescribed by the Radiation Oncologist and the Radiation Physician in the treatment of patients with HL were very similar. The mean dose to the heart was “low” (below 28 Gy). However, there was a wide range of individual doses that exceeded this criterion. Patients who receive neither target volume nor heart dose above 28 Gy are at significant risk of developing cardiomyopathy as a consequence of radiation exposure." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"Lymphoma is a group of cancers that are caused by uncontrollable growth and proliferation of a abnormal population of white blood cells. These cells are called lymphocytes. The exact definition of lymphoma varies greatly depending upon the country in which a diagnosis is made.\nWell differentiated lymphoma is generally a form of lymphoid leukemia, while poorly differentiated lymphoma is usually a more aggressive subtype of diffuse large B-cell lymphoma. The distinction between well and poorly differentiated forms of lymphoma is blurred. Usually, the poorly differentiated form is more aggressive and can be treated differently than the well differentiated form. However, both types can be treated with chemotherapy, steroids, or radiotherapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"There are many signs and symptoms of lymphoma; the severity depends on the type of lymphoma. All patients who present with fever, night sweats, weight loss and/or swelling should be evaluated for possible lymphoma\n" - Anonymous Online Contributor

Unverified Answer

What are the latest developments in radiation - dose level 0 for therapeutic use?

"Current radiation dose levels encompass a wide range of doses ranging from low levels (<1 Gy) to high levels (>30 Gy). Radiation dose levels>30 Gy may be considered as local radiotherapy for localized HL and high doses (>30 Gy) may be used as systemic therapy for disseminated HL." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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