Photodynamic Therapy Using Blue Light or Red Light in Treating Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Basal Cell Carcinoma of the Skin Clinical Trial

Official title:

Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During LevulanTM-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02258243
• Other study ID #: CASE2614
• Secondary ID: NCI-2014-02037CA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 3, 2014
• Last updated: November 4, 2016
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This pilot randomized phase II trial studies how well photodynamic therapy using blue light or red light works in treating basal cell cancer (carcinoma) in patients with a genetic condition that causes unusual facial features and disorders of the skin, bones, nervous system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor cells and when exposed to an intensive light source (blue light or red light) become active and may kill the cells. It is not yet known whether photodynamic therapy is more effective with blue light or red light in treating basal cell carcinoma.

Description:

PRIMARY OBJECTIVES:

I. To determine whether cyclic photodynamic therapy (PDT) treatment is effective in curing existing basal cell carcinoma (BCC) tumors in patients with basal cell nevus syndrome (BCNS), and whether red light or blue light is more effective in this regard.

SECONDARY OBJECTIVES:

I. To assess the tolerability (pain during treatment) of red light versus blue light in this patient population.

II. To assess patient satisfaction with the technique.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the left side of the body and red light on the right side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the right side of the body and red light on the left side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097)

• Major criteria are:

• BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type

• Keratocyst of the jaw prior to age 20

• Palmar or plantar pitting

• Lamellar calcification of the falx cerebri

• Medulloblastoma

• First degree relative with BCNS

• Minor criteria are:

• Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals

• Macrocephaly

• Cleft/lip or palate

• Fibroma of the heart or ovary

• Ocular abnormalities

• Other rare abnormalities listed in the article by Bree et al

• For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a patched 1 (PTCH1) gene mutation

• At least two BCC tumors, preferably more; these tumors must be located in different body regions or alternatively, located > 10 cm apart at sites that can be reproducibly separated into red and blue illumination fields

• Female subjects must not become pregnant during the study; women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry, and for the duration of study participation; should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately

• Subjects must be able to understand and be willing to sign a written informed consent document

Exclusion Criteria:

• Pregnant or nursing

• Currently participating in another clinical trial

• Using any topical treatment for their BCC tumors, unless discontinued at least one month prior.

• Currently being treated for other cancers with medical or radiation therapy

• Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material

• Patients with history of a photosensitivity disease, such as porphyria cutanea tarda

• General or specific aspects of the patient's condition render the patient unacceptable for this treatment in the judgment of the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma of the Skin
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Nevoid Basal Cell Carcinoma Syndrome
• Syndrome

Intervention

Drug:
• aminolevulinic acid hydrochloride
Applied topically
• photodynamic therapy
Undergo PDT using blue light on the left side of the body and red light on the right side of the body
• photodynamic therapy
Undergo PDT using blue light on the right side of the body and red light on the left side of the body

Other:
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor diameter as a function of time		Up to 6 months	No
Primary	Mean reduction in tumor diameter measured via digital imaging software		Up to 6 months	No
Primary	Mean reduction in number of tumors		Up to 6 months	No
Primary	Number of lesions with complete response (CR) measured via digital imaging software	Generalized linear mixed-effects models will be applied to categorical endpoints.	Up to 6 months	No
Primary	Number of lesions with partial response measured via digital imaging software		Up to 6 months	No
Primary	Number of lesions with no response measured via digital imaging software		Up to 6 months	No
Primary	Average time to clearance for lesions with a CR	Recorded photographically. The analysis for time to clearance will be based on a random-frailty survival model, where lesions without CR will be considered to have clearance times censored at the end of study.	Up to 6 months	No
Primary	Percent of lesions with a CR, as a function of initial tumor size	Recorded photographically.	Up to 6 months	No
Primary	Time to recurrence, following CR, in a given PDT-treated field		Up to 2 years	No
Primary	Protoporphyrin IX levels in tumors via noninvasive fluorescence dosimetry		Up to 6 months post-treatment	No
Secondary	Pain during treatment using patient's symptom score sheets	The absence/presence of pain will be recorded on a 0-to-10 visual/analog scale.	Up to 4 months	No
Secondary	Patient satisfaction using a short questionnaire		Up to 6 months	No