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New treatment option for Basal Cell Carcinoma (BCC)
Official title Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
ClinicalTrials.gov ID: NCT06623201
What this study is testing
What is aminolevulinic acid HCL (ALA)?
aminolevulinic acid HCL (ALA) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for basal cell carcinoma (bcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will be included in the study based on the following criteria:
- Male or females, at least 18 years of age.
- 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.
- Diagnosis must be confirmed clinically at baseline with 1-3 lesions having been biopsied no sooner than 2 weeks prior to treatment.
- Patients who may have high burden of disease (i.e., large lesions), who are non-surgical candidates or who refuse surgery.
You likely can't join if
- Patients will be excluded from the study based on the following criteria:
- Sexually active women of childbearing (WOCBP)\ who are unwilling to practice highly effective contraception prior to the initial dose/start of the...
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal...
- Intrauterine device (IUD); intrauterine hormone-releasing system
- Bilateral tubal ligation;
- Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
See the full eligibility criteria
Who can join
- Patients will be included in the study based on the following criteria:
- Male or females, at least 18 years of age.
- 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.
- Diagnosis must be confirmed clinically at baseline with 1-3 lesions having been biopsied no sooner than 2 weeks prior to treatment.
- Patients who may have high burden of disease (i.e., large lesions), who are non-surgical candidates or who refuse surgery.
- 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.
- Patients in whom surgery or radiation therapy may be impractical.
- Primary lesions may be acceptable for enrollment.
- 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.
- 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.
- Ability to understand and the willingness to sign a written informed consent document in English.
What rules you out
- Patients will be excluded from the study based on the following criteria:
- 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...
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- Intrauterine device (IUD); intrauterine hormone-releasing system
- Bilateral tubal ligation;
- Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
- 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...
- 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.
- people who plan on donating blood or blood products during the study and for at least 20 months after the last dose of treatment. Male people must agree not to donate sperm during the study and for at least 8 months...
- Target lesions of basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular).
- Any BCC that may require Mohs surgery for definitive control as a target lesion.
- people with porphyria's or known hypersensitivity to porphyrins.
- people with known photosensitivity diseases.
- people previously treated with a systemic photosensitizer within 4 months of screening date.
- people who desire to get pregnant a female of childbearing potential within the next 1.5 years.
- 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...
- Life expectancy less than one year.
- Inability or unwillingness to swallow capsules.
- 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.
- 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.
- Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit.
- people who have received any type of solid organ transplant.
- people taking immunosuppressive medications at the screening visit that interact with Sonidegib at the screening visit unless approved by the investigator..
- 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. people cannot...
- 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...
- people unable or unwilling to comply with the study visit schedule and requirements of the study.
- people unable to speak and read the English language.
- A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
- A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.