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Trial record 3 of 168 for:    Recruiting, Not yet recruiting, Available Studies | "Mycoses"

Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

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ClinicalTrials.gov Identifier: NCT03281811
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Refractory Mycosis Fungoides Drug: Aminolevulinic Acid Hydrochloride Drug: Photodynamic Therapy Other: Quality-of-Life Assessment Radiation: Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF).

SECONDARY OBJECTIVES:

I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF.

EXPLORATORY OBJECTIVES:

I. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019


Arm Intervention/treatment
Experimental: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
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.
Drug: Aminolevulinic Acid Hydrochloride
Given topically
Other Names:
  • .delta.-Aminolevulinic acid hydrochloride
  • Alacare
  • Ameluz
  • Aminolevulinic Acid HCl
  • Delta-Aminolevulinic Acid HCl
  • Delta-Aminolevulinic Acid Hydrochloride
  • Levulan
  • Levulan Kerastick

Drug: Photodynamic Therapy
Undergo PDT
Other Names:
  • PDT
  • Photoradiation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  1. Complete clinical response [ Time Frame: At 24 weeks ]
    Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).


Secondary Outcome Measures :
  1. Change in CAILS score [ Time Frame: Baseline up to week 24 ]
    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.

  2. Change in field of treatment [ Time Frame: Baseline up to week 24 ]
    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.

  3. Change in Skindex-16 score [ Time Frame: Baseline up to week 24 ]
    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.

  4. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
    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.


Other Outcome Measures:
  1. Patient-reported outcomes [ Time Frame: Up to 2 years ]
    Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms, as well as with clinical outcomes (response) and clinician-assessed symptoms (National Cancer Institute [NCI] CTCAE v4).

  2. Quality of life (QOL) [ Time Frame: Up to 2 years ]
    Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes (response) and clinician-assessed symptoms (NCI CTCAE v4).



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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:

  • 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)

Exclusion Criteria:

  • 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
  • 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

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): NCT03281811


Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Aaron Mangold         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aaron Mangold Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03281811     History of Changes
Other Study ID Numbers: MC168B
NCI-2017-01649 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC168B ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents