Basal Cell Cancer, Basal Cell Carcinoma, BCC, BCC - Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, Superficial Basal Cell Carcinoma
Conditions
Keywords
Superficial BBC, Nodular BBC, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, BCC, Basal Cell Carcinoma, PDT treatment, photodynamic therapy, Jet injection, Memorial Sloan Kettering Cancer Center, 20-270
Brief summary
The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.
Interventions
DRUGJet injection of ALA
The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap).
PROCEDURESurgical excision
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
PROCEDUREIllumination
For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16).
OTHERIncubation
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who meet all of the following criteria are eligible to participate in this study * Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) \< 1 cm in diameter on scalp, extremities, or trunk. * ≥ 18 years of age * Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study. * Being able to download application on their phone * Being able to take pictures of their treated BCC(s) (with or without assistance) * Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit) * Legally competent, able to give verbal and written informed consent * Subject in good general health and willing to participate comply with protocol requirements. * Superficial and nodular BCC(s)
Exclusion criteria
Subjects meeting any one of the following criteria are not eligible to participate in this study * High-risk BCC(s) (H area, \>1 cm in M area, or \>2 cm in L area) * BCC(s) subtype morpheaform * Diagnosed with gorlin syndrome * Receiving immunosuppressive medication * Subjects with a known allergy to ALA * Individuals with other interfering skin diseases in the area of treatment * Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study * Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator * Lactating or pregnant women * Patient who are taking prescription pain medications or can not stop OTC pain medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation of Local Skin Responses on Day 0 | Baseline (Day 0) | Clinical evaluation of local skin responses will be performed at Day 0 (PDT treatment #1). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
| Clinical Evaluation of Local Skin Responses on Day 3 | Day 3 | Clinical evaluation of local skin responses will be performed at Day 3. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
| Clinical Evaluation of Local Skin Responses on Day 14 | Day 14 | Clinical evaluation of local skin responses will be performed at Day 14 (PDT treatment #2). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
| Clinical Evaluation of Local Skin Responses on Day 17 | Day 17 | Clinical evaluation of local skin responses will be performed at Day 17. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
| Clinical Evaluation of Local Skin Responses 3 Months Post Treatment | 3 months after treatment | Clinical evaluation of local skin responses will be performed 3 months post treatment. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnthony Rossi, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 12 |
| other Total, other adverse events | 0 / 4 | 1 / 12 |
| serious Total, serious adverse events | 0 / 4 | 1 / 12 |
Outcome results
None listed