Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

NCT03281811 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: MC168BNCI-2017-01649
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Complete clinical response

  Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).

  At 24 weeks

Secondary Outcomes (4)

• Change in CAILS score

  Baseline up to week 24

• Change in field of treatment

  Baseline up to week 24

• Change in Skindex-16 score

  Baseline up to week 24

• Incidence of adverse events (AEs)

  Up to 2 years

Other Outcomes (2)

• Patient-reported outcomes

  Up to 2 years

• Quality of life (QOL)

  Up to 2 years

Study Arms (1)

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.

Drug: Aminolevulinic Acid Hydrochloride; Drug: Photodynamic Therapy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

Interventions

Aminolevulinic Acid Hydrochloride DRUG

Given topically

Also known as: .delta.-Aminolevulinic acid hydrochloride, Alacare, Ameluz, Aminolevulinic Acid HCl, Delta-Aminolevulinic Acid HCl, Delta-Aminolevulinic Acid Hydrochloride, Levulan, Levulan Kerastick

Treatment (aminolevulinic acid hydrochloride, PDT, RT)

Photodynamic Therapy DRUG

Undergo PDT

Also known as: PDT, Photoradiation Therapy

Treatment (aminolevulinic acid hydrochloride, PDT, RT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (aminolevulinic acid hydrochloride, PDT, RT)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (aminolevulinic acid hydrochloride, PDT, RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Aminolevulinic Acid; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Phototherapy; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Physical Phenomena

Study Officials

• Aaron Mangold

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: November 13, 2017
• Primary Completion: February 25, 2020
• Study Completion: August 12, 2020
• Last Updated: January 5, 2023

Record last verified: 2021-02

Locations

US (1)