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

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ClinicalTrials.gov Identifier: NCT02258243
Recruitment Status : Active, not recruiting
First Posted : October 7, 2014
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma of the Skin Nevoid Basal Cell Carcinoma Syndrome Drug: aminolevulinic acid hydrochloride Drug: photodynamic therapy Other: laboratory biomarker analysis Other: questionnaire administration Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Arm I (PDT using blue light on left and red light on right)
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.
Drug: aminolevulinic acid hydrochloride
Applied topically
Other Names:
  • 5-ALA HCl
  • ALA HCl
  • aminolevulinic acid HCl

Drug: photodynamic therapy
Undergo PDT using blue light on the left side of the body and red light on the right side of the body
Other Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic

Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies

Experimental: Arm II (PDT using blue light on right and red light on left)
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.
Drug: aminolevulinic acid hydrochloride
Applied topically
Other Names:
  • 5-ALA HCl
  • ALA HCl
  • aminolevulinic acid HCl

Drug: 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 Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic

Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies




Primary Outcome Measures :
  1. Tumor diameter as a function of time [ Time Frame: Up to 6 months ]
  2. Mean reduction in tumor diameter measured via digital imaging software [ Time Frame: Up to 6 months ]
  3. Mean reduction in number of tumors [ Time Frame: Up to 6 months ]
  4. Number of lesions with complete response (CR) measured via digital imaging software [ Time Frame: Up to 6 months ]
    Generalized linear mixed-effects models will be applied to categorical endpoints.

  5. Number of lesions with partial response measured via digital imaging software [ Time Frame: Up to 6 months ]
  6. Number of lesions with no response measured via digital imaging software [ Time Frame: Up to 6 months ]
  7. Average time to clearance for lesions with a CR [ Time Frame: Up to 6 months ]
    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.

  8. Percent of lesions with a CR, as a function of initial tumor size [ Time Frame: Up to 6 months ]
    Recorded photographically.

  9. Time to recurrence, following CR, in a given PDT-treated field [ Time Frame: Up to 2 years ]
  10. Protoporphyrin IX levels in tumors via noninvasive fluorescence dosimetry [ Time Frame: Up to 6 months post-treatment ]

Secondary Outcome Measures :
  1. Pain during treatment using patient's symptom score sheets [ Time Frame: Up to 4 months ]
    The absence/presence of pain will be recorded on a 0-to-10 visual/analog scale.

  2. Patient satisfaction using a short questionnaire [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02258243


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Edward Maytin Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02258243     History of Changes
Other Study ID Numbers: CASE2614
NCI-2014-02037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE2614
CASE 2614 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Syndrome
Carcinoma
Carcinoma, Basal Cell
Basal Cell Nevus Syndrome
Disease
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents