Refractory Mycosis FungoidesEarly Phase 1NCT03281811
Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides
A Early Phase 1 study testing Aminolevulinic Acid Hydrochloride, Photodynamic Therapy and Quality-of-Life Assessment in people with Refractory Mycosis Fungoides, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Mycosis Fungoides
- What is being tested?
- Aminolevulinic Acid Hydrochloride, Photodynamic Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 12 Aug 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Histological confirmation of mycosis fungoides as confirmed by the Mayo Clinic Arizona Dermatopathology Department
- Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to 4 lesions in a single field of PDT or RT will be considered for treatment):
- Plaque stage disease that has failed at least 2 skin directed therapies (including topical steroids) or refractory plaques despite at least one systemic therapy or plaques with evidence of folliculotropism
- The presence of a tumor of MF
- Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Who cannot join
- Prior radiation to the same site deemed to be too high of level of radiation for retreatment
- Photosensitivity disorder, including but not limited to porphyria, or concomitant photosensitizing drugs that place the patient at an elevated risk of developing severe side effects to PDT or RT
- Skin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell carcinoma in situ in the field of RT
- Active infection at the site to be irradiated
- Any underlying condition which prevents the patient from being able to undergo the required number of sessions of PDT or RT and required follow up
- Pregnancy
Show all 17Show fewer
- Lactation and a radiation field which would include the breast or nipple or deemed to place the mother or child at elevated risk of radiation exposure (evaluated by MRP, ARM, WR, WW)
- An allergy to a component of Levulan
- Women of childbearing potential (post-menopausal or not of child-bearing potential) is defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:
- Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception)
- Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment; oophorectomy alone requires follow up hormone level assessment for fertility
- Male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that subject
- Barrier methods of contraception: condom or occlusive cap
- Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%); (the dose of the contraceptive should be stable for 3 months)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides
This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF).
SECONDARY OBJECTIVES:
- To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF.
EXPLORATORY OBJECTIVES:
- To determine the quality of life during and after treatment.
OUTLINE:
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
After completion of study treatment, patients are followed up for up to 8 weeks.
- Conditions
- Refractory Mycosis Fungoides
- Being tested
- Aminolevulinic Acid Hydrochloride, Photodynamic Therapy, Quality-of-Life Assessment, Radiation Therapy
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid HydrochlorideDrug
Also called .delta.-Aminolevulinic acid hydrochloride, Alacare, Ameluz, Aminolevulinic Acid HCl
Given topically
Photodynamic TherapyDrug
Also called PDT, Photoradiation Therapy
Undergo PDT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (aminolevulinic acid hydrochloride, PDT, RT) | Experimental | Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks. Receives: Drug: Aminolevulinic Acid Hydrochloride; Drug: Photodynamic Therapy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response
Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).
Measured: At 24 weeks
Secondary outcomes (4)
Change in CAILS score
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Measured: Baseline up to week 24
Change in field of treatment
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Measured: Baseline up to week 24
Change in Skindex-16 score
Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Measured: Baseline up to week 24
Incidence of adverse events (AEs)
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start13 Nov 2017
- Primary completion25 Feb 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aaron Mangold, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281811
- Sponsor's protocol ID
- MC168B
- Other IDs
- NCI-2017-01649, MC168B
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2017
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides
- ClinicalTrials.gov ID
- NCT03281811
- Acronym / sponsor ID
- MC168B
- Conditions
- Refractory Mycosis Fungoides
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF).
SECONDARY OBJECTIVES:
- To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF.
EXPLORATORY OBJECTIVES:
- To determine the quality of life during and after treatment.
OUTLINE:
Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
After completion of study treatment, patients are followed up for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (aminolevulinic acid hydrochloride, PDT, RT) | Experimental | Drug: Aminolevulinic Acid Hydrochloride, Drug: Photodynamic Therapy, Other: Quality-of-Life Assessment, Radiation: Radiation TherapyPatients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological confirmation of mycosis fungoides as confirmed by the Mayo Clinic Arizona Dermatopathology Department
- Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to 4 lesions in a single field of PDT or RT will be considered for treatment):
- Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
Key exclusion criteria (17 listed)
- Prior radiation to the same site deemed to be too high of level of radiation for retreatment
- Photosensitivity disorder, including but not limited to porphyria, or concomitant photosensitizing drugs that place the patient at an elevated risk of developing severe side effects to PDT or RT
- Skin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell carcinoma in situ in the field of RT
- Active infection at the site to be irradiated
- Any underlying condition which prevents the patient from being able to undergo the required number of sessions of PDT or RT and required follow up
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 |
|---|---|---|
| Aminolevulinic Acid HydrochlorideAlso: .delta.-Aminolevulinic acid hydrochloride, Alacare, Ameluz, Aminolevulinic Acid HClGiven topically | Drug | Treatment (aminolevulinic acid hydrochloride, PDT, RT) |
| Photodynamic TherapyAlso: PDT, Photoradiation TherapyUndergo PDT | Drug | Treatment (aminolevulinic acid hydrochloride, PDT, RT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (aminolevulinic acid hydrochloride, PDT, RT) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, irradiationUndergo RT | Radiation | Treatment (aminolevulinic acid hydrochloride, PDT, RT) |
Primary outcome
Complete clinical response
Time frame: At 24 weeks
Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).
4 secondary outcomes
Change in CAILS score
Time frame: Baseline up to week 24
Change in field of treatment
Time frame: Baseline up to week 24
Change in Skindex-16 score
Time frame: Baseline up to week 24
Incidence of adverse events (AEs)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Mayo Clinic Clinical TrialsLink 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.
Aaron Mangold principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aminolevulinic Acid Hydrochloride, Photodynamic Therapy and Quality-of-Life Assessment in people with Refractory Mycosis Fungoides, run by Mayo Clinic 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 17 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 5 Jan 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete clinical response (time frame: At 24 weeks). 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 5 Jan 2023.