Clinical trial NCT06623201: Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Official title: Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Basal Cell Carcinoma (BCC)
Keywords: Basal cell carcinoma
Levulan
PDT
Lead sponsor: US Dermatology Partners, Phoenix
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label study where all participants receive the same treatment
Primary purpose: TREATMENT

Brief summary: This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions.

Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.

Detailed description: Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective of this study is to evaluate the safety and efficacy of using photodynamic Therapy with Sonidegib for the treatment of multiple nodular basal cell carcinomas. Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months. Participants will undergo three PDT sessions with topical application of ALA at Day 7, Day 30, and Day 90.

The drug applied to the skin before the light treatment is an FDA approved drug called Levulan and has no known side effects. The light used to treat the lesion is blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator (Levulan-PDT). This treatment regimen is approved by the FDA to treat actinic keratoses, but is not approved to treat basal cell carcinoma. Use of the light can feel warm and may sting.

Sonidegib (Odomzo) is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC. Patients on Sonidegib may experience leg cramps, taste disturbance, or alopecia

Eligibility criteria: Patients will be included in the study based on the following criteria:

1. Male or females, at least 18 years of age
2. Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities.
3. Diagnosis must be confirmed clinically at baseline with 1-2 lesions having been biopsied no sooner than 2 weeks prior to treatment.
4. Patients who may have high burden of disease ie large lesions, who are non-surgical candidates or who refuse surgery.
5. Non-surgical candidates, who may be able to undergo resection of selected single, individual lesion, but may not tolerate extensive surgery, may have many co morbidities, may be prone to complications.
6. Patients in whom surgery or radiation therapy may be impractical
7. Primary lesions may be acceptable for enrollment
8. Within normal limit hematopoietic capacity, hepatic and renal function. Values outside those limits may be allowed at the discretion of the PI, if they are determined as not clinically significant
9. Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
10. Ability to understand and the willingness to sign a written informed consent document in English

Exclusion Criteria

Patients will be excluded from the study based on the following criteria:

1. Sexually active women of childbearing (WOCBP)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for 20 months after the final dose of treatment. Highly effective contraceptive measures include:

   1. Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation
   2. Intrauterine device (IUD); intrauterine hormone-releasing system
   3. Bilateral tubal ligation;
   4. Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
   5. and/or sexual abstinence

      * Childbearing potential refers to a female who has reached menarche, has not had a surgical sterilization procedure (such as a hysterectomy or bilateral oophorectomy), and is not postmenopausal. Menopause is defined as 12 consecutive months of amenorrhea without other biological causes. Furthermore, for females under 55 years old, a serum follicle-stimulating hormone level greater than 40 mIU/mL must be documented to confirm menopause.
2. Sexually active males who are unwilling to use a condom with female partners of childbearing potential, during the study, and for at least 8 months after the last dose of treatment
3. Subjects who plan on donating blood or blood products during the study and for at least 20 months after the last dose of treatment. Male subjects must agree not to donate sperm during the study and for at least 8 months after the last dose of treatment.
4. Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
5. Any BCC that may require Mohs surgery for definitive control
6. Subjects with porphyria's or known hypersensitivity to porphyrins
7. Subjects with known photosensitivity diseases
8. Subjects previously treated with a systemic photosensitizer within 4 months of screening date
9. Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years
10. Uncontrolled concomitant 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.
11. Life expectancy less than one year
12. Inability or unwillingness to swallow capsules
13. Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed.
14. Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
15. Having used any of the following treatment within 6 months before the baseline visit:

    * hedgehog pathway inhibitor, biologics, or chemotherapy
    * topical chemotherapy agents including Imiquimod, fluorouracil,) to the selected treatment lesion sites within 3 weeks
16. Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit
17. Subjects who have received any type of solid organ transplant
18. Subjects taking immunosuppressive medications at the screening visit.
19. Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
21. Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
22. Subjects unable to speak and read the English language
23. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.

Primary outcomes:
measure: Primary efficacy outcome
timeFrame: From enrollment to day 180
measure: Review of AEs likely related to study drug
timeFrame: From enrollment to day 180
Secondary outcomes:
measure: Review of disease progression
timeFrame: From enrollment to day 180
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
Study officials:
affiliation: Medical Dermatology Specialists
name: Nathalie Zeitouni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Itkin A, Gilchrest BA. delta-Aminolevulinic acid and blue light photodynamic therapy for treatment of multiple basal cell carcinomas in two patients with nevoid basal cell carcinoma syndrome. Dermatol Surg. 2004 Jul;30(7):1054-61. doi: 10.1111/j.1524-4725.2004.30317.x.
citation: Maytin EV, Kaw U, Ilyas M, Mack JA, Hu B. Blue light versus red light for photodynamic therapy of basal cell carcinoma in patients with Gorlin syndrome: A bilaterally controlled comparison study. Photodiagnosis Photodyn Ther. 2018 Jun;22:7-13. doi: 10.1016/j.pdpdt.2018.02.009. Epub 2018 Feb 19.
citation: Lanoue J, Goldenberg G. Basal Cell Carcinoma: A Comprehensive Review of Existing and Emerging Nonsurgical Therapies. J Clin Aesthet Dermatol. 2016 May;9(5):26-36. Epub 2016 May 1.
citation: Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008 Oct;8(10):743-54. doi: 10.1038/nrc2503.