LymphomaPhase 2NCT01073267
Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides
A Phase 2 study testing TSEBT in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- TSEBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed mycosis fungoides in stage IB-IIIA
- Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
- 18 years of age or older
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) of </= 2
- Adequate bone marrow function: White blood count (WBC) >/= 2000/uL; platelet count>/= 100,000/mm3; Absolute neutrophil count (ANC) >/= 1000
- Required wash out period for prior therapies (Note: patients with progressive disease may be treated earlier than required washout period per Investigator's decision) a) Topical therapy: 2 weeks, b) Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks, c) Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks, d) Other investigational therapy: 4 weeks
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
- Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
- Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
- Pregnant or lactating
- Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; 'prescription strength' topical corticosteroids cannot be started during the study)
- Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.
Read the detailed description
Study Radiation:
During total skin electron beam therapy, radiation is given to the entire surface of the skin. This may cause the cancer cells to die.
Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.
Screening Period:
Signing this consent form does not mean that you will be able to take part in this study. You will have the following "screening tests" to help the doctor decide if you are eligible to take part in this study.
Within 6 weeks before the radiation therapy can begin:
- If the doctor thinks it is needed, you will have a computed tomography (CT) scan or other type of scan to check the status of the disease.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for cancer in your lymph nodes.
Within 4 weeks before the radiation therapy can begin:
- Your medical history will be recorded, including any drugs you are taking and have taken.
- You will have a physical exam, including a skin exam and measurement of your weight and vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Women who are able to become pregnant must have a negative urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Wash-Out Period:
If you agree to take part in this study, from that day until your first study radiation treatment, you will stop certain treatments for mycosis fungoides. This is called a "wash-out period". The number of weeks will be different depending on what treatments you may be receiving. The study doctor will explain the types of treatments and schedule for stopping them.
- For the 2 weeks before radiation, you will stop using any cancer drugs that are "topical" (applied onto the skin).
- For the 4 weeks before radiation, you will stop any radiation therapy, phototherapy (cancer treatments with light), cancer drugs that are "systemic" (affecting the whole body), and any other investigational therapy.
Study Visit Before Radiation Therapy:
Within 1 week before your first radiation treatment, the following tests and procedures will be performed:
-You will have a physical exam, including a skin exam and measurement of your weight and vital signs.
Your performance status will be recorded.
- You will be asked about any drugs you may be taking.
- The doctor will draw on your skin with a marker to mark areas of your body that are unexposed. This is to help plan the radiation treatments. Depending on your body shape, about 8-16 body areas will be marked.
- Photos will be taken of your whole body. These photos will be used to help the doctor find out how much skin is affected by the disease.
Radiation Treatments:
If you are found to be eligible to take part in this study, you will receive low-dose radiation to the skin 4-5 days a week for 3 weeks.
On Mondays and Tuesdays, you will receive radiation that can cover your entire skin area. You will be standing during the treatment. This wider-field radiation treatment cannot give enough radiation to the unexposed areas of your body, such as under the arms, under the breasts for females, under the belly, in the private areas, and the soles of the feet. For this reason, in addition to the wider-field radiation, you will also receive radiation that covers these smaller areas of your body on Wednesdays and Thursdays. The amount of radiation that these smaller body areas will receive is designed to be the same as the amount the rest of the skin will receive.
If the study doctor thinks it is needed for standard care, you will also receive radiation treatments on other tumors. In most cases, this will be on Fridays. It will be 4-7 treatments, depending on the tumor size.
At Weeks 2 and 3 of radiation treatment, you will be asked about any side effects that have occurred.
Length of Study:
You may receive up to 3 weeks of low-dose radiation therapy. You will be taken off the study treatment early if intolerable side effects occur or the disease gets worse. The follow-up period in this study lasts up to 12 months after the last treatment.
Follow-Up and End-of-Study Visits:
After your last dose of low-dose radiation therapy, you will have follow-up visits 1 to 3 weeks after treatment, every 2 months for 6 months, and then every 3 months for a total of 12 months. However, if the disease gets worse during this 12-month follow-up period, the follow-up visits will stop. When you are off-study, an end-of-study visit will occur.
If you stopped the radiation early due to intolerable side effects, you will have follow-up visits twice a week until the doctor thinks the side effects have gotten better. After that, you will return for an end-of-study visit.
At the follow-up visits and end-of-study visit, the following tests and procedures will be performed:
- You will have a physical exam, including a skin exam and measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and side effects that may have occurred.
- Photos will be taken of your whole body to check the status of the disease.
- Blood (about 1 teaspoon) will be drawn for routine tests
This is an investigational study. For this type of cancer, the dose of radiation in this study is lower than standard. The type of radiation therapy (total skin electron beam therapy) is standard. At this time, the lower dose is only being used in research.
Up to 20 patients will be take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Being tested
- TSEBT
- Keywords
- Stage IB-IIIA Mycosis fungoides, Total Skin Electron Beam Therapy, TSEBT
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSEBTRadiation
Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TSEBT | Experimental | Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy Receives: Radiation: TSEBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).
Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score.
Measured: Baseline and at least 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouthaina Dabaja, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073267
- Sponsor's protocol ID
- 2009-0444
- Other IDs
- NCI-2011-00560
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2010
- Last updated
- 31 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
- ClinicalTrials.gov ID
- NCT01073267
- Acronym / sponsor ID
- 2009-0444
- Conditions
- Lymphoma
- Keywords
- Stage IB-IIIA Mycosis fungoides, Total Skin Electron Beam Therapy, TSEBT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 31 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.
Detailed description
Study Radiation:
During total skin electron beam therapy, radiation is given to the entire surface of the skin. This may cause the cancer cells to die.
Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.
Screening Period:
Signing this consent form does not mean that you will be able to take part in this study. You will have the following "screening tests" to help the doctor decide if you are eligible to take part in this study.
Within 6 weeks before the radiation therapy can begin:
- If the doctor thinks it is needed, you will have a computed tomography (CT) scan or other type of scan to check the status of the disease.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for cancer in your lymph nodes.
Within 4 weeks before the radiation therapy can begin:
- Your medical history will be recorded, including any drugs you are taking and have taken.
- You will have a physical exam, including a skin exam and measurement of your weight and vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Women who are able to become pregnant must have a negative urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Wash-Out Period:
If you agree to take part in this study, from that day until your first study radiation treatment, you will stop certain treatments for mycosis fungoides. This is called a "wash-out period". The number of weeks will be different depending on what treatments you may be receiving. The study doctor will explain the types of treatments and schedule for stopping them.
- For the 2 weeks before radiation, you will stop using any cancer drugs that are "topical" (applied onto the skin).
- For the 4 weeks before radiation, you will stop any radiation therapy, phototherapy (cancer treatments with light), cancer drugs that are "systemic" (affecting the whole body), and any other investigational therapy.
Study Visit Before Radiation Therapy:
Within 1 week before your first radiation treatment, the following tests and procedures will be performed:
-You will have a physical exam, including a skin exam and measurement of your weight and vital signs.
Your performance status will be recorded.
- You will be asked about any drugs you may be taking.
- The doctor will draw on your skin with a marker to mark areas of your body that are unexposed. This is to help plan the radiation treatments. Depending on your body shape, about 8-16 body areas will be marked.
- Photos will be taken of your whole body. These photos will be used to help the doctor find out how much skin is affected by the disease.
Radiation Treatments:
If you are found to be eligible to take part in this study, you will receive low-dose radiation to the skin 4-5 days a week for 3 weeks.
On Mondays and Tuesdays, you will receive radiation that can cover your entire skin area. You will be standing during the treatment. This wider-field radiation treatment cannot give enough radiation to the unexposed areas of your body, such as under the arms, under the breasts for females, under the belly, in the private areas, and the soles of the feet. For this reason, in addition to the wider-field radiation, you will also receive radiation that covers these smaller areas of your body on Wednesdays and Thursdays. The amount of radiation that these smaller body areas will receive is designed to be the same as the amount the rest of the skin will receive.
If the study doctor thinks it is needed for standard care, you will also receive radiation treatments on other tumors. In most cases, this will be on Fridays. It will be 4-7 treatments, depending on the tumor size.
At Weeks 2 and 3 of radiation treatment, you will be asked about any side effects that have occurred.
Length of Study:
You may receive up to 3 weeks of low-dose radiation therapy. You will be taken off the study treatment early if intolerable side effects occur or the disease gets worse. The follow-up period in this study lasts up to 12 months after the last treatment.
Follow-Up and End-of-Study Visits:
After your last dose of low-dose radiation therapy, you will have follow-up visits 1 to 3 weeks after treatment, every 2 months for 6 months, and then every 3 months for a total of 12 months. However, if the disease gets worse during this 12-month follow-up period, the follow-up visits will stop. When you are off-study, an end-of-study visit will occur.
If you stopped the radiation early due to intolerable side effects, you will have follow-up visits twice a week until the doctor thinks the side effects have gotten better. After that, you will return for an end-of-study visit.
At the follow-up visits and end-of-study visit, the following tests and procedures will be performed:
- You will have a physical exam, including a skin exam and measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and side effects that may have occurred.
- Photos will be taken of your whole body to check the status of the disease.
- Blood (about 1 teaspoon) will be drawn for routine tests
This is an investigational study. For this type of cancer, the dose of radiation in this study is lower than standard. The type of radiation therapy (total skin electron beam therapy) is standard. At this time, the lower dose is only being used in research.
Up to 20 patients will be take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSEBT | Experimental | Radiation: TSEBTTotal Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy-confirmed mycosis fungoides in stage IB-IIIA
- Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
- 18 years of age or older
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) of </= 2
Key exclusion criteria (6 listed)
- Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
- Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
- Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
- Pregnant or lactating
- Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; 'prescription strength' topical corticosteroids cannot be started during the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSEBTTotal skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. | Radiation | TSEBT |
Primary outcome
Objective Response Rate
Time frame: Baseline and at least 2 months
Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT). Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouthaina Dabaja, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TSEBT in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Baseline and at least 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.