Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas

NCT02639117 | Completed Phase 1 DMC

• 1 other identifier: 1511201549
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 single site study to evaluate the safety and efficacy of a combination therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions with topical application of ALA. The PDT will be first administered at 7+ 4 business days after the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business days. Primary Objective The primary objective of this study is to determine the safety of photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple BCC. 3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study subjects who has complete or partial response to the study treatment.

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma, photodynamic therapy, vismodegib

Outcome Measures

Primary Outcomes (1)

• The number of participants with treatment related adverse events as assessed by the CTCAE v4.0

  The proportion of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.

  2 years

Secondary Outcomes (5)

• The number of participants with overall response rate

  2 years

• The number of participants wtih progressive disease or stable disease

  2 years

• The number of patients with complete histological clearance

  2 years

• Overall treatment related pain during PDT assessed with the 11 point visual analogue scale (VAS) .

  2 years

• Overall cosmetic scores on a scale of 1-5.

  2 years

Study Arms (1)

Vismodegib

OTHER

Vismodegib 150 mgs po qd. Open label.

Drug: Vismodegib

Interventions

Vismodegib DRUG

Vismodegib 150 mgs po qd for 3 months

Also known as: Erivedge

Vismodegib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included in the study based on the following criteria:
• Male or non-childbearing potential females, at least 18 years of age (Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential)
• ≥ 50 years old and naturally amenorrheic for ≥ 1 year
• Permanent premature ovarian failure confirmed by specialist gynecologist
• Previous bilateral salpingo-oophorectomy or hysterectomy
• XY karyotype, Turner's syndrome, or uterine agenesis
• Diagnosis of BCC with at least 4 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 1-2 lesions having been biopsied no sooner than 2 weeks prior to treatment.
• Patients who may have high burden of disease ie 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 digression of the PI, if they are determined as not clinically significant
• Male patients must use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 3 months after the last dose to avoid exposing a pregnant partner and unborn fetus to vismodegib
• Male patients must agree not to donate sperm during the study and for 3 months after discontinuation of vismodegib

You may not qualify if:

• Women of childbearing potential
• Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
• Any BCC that may require Mohs surgery for definitive control
• Subjects with porphyria's or known hypersensitivity to porphyrins
• Subjects with known photosensitivity diseases
• Subjects previously treated with a systemic photosensitizer within 4 months of screening date
• Subjects 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 that would limit compliance with study requirements.
• 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.
• Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
• Currently receiving vismodegib, biologics or chemotherapy
• Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including Imiquimod, fluorouracil, Ingenol mebutate (picato) to the selected treatment lesion sites.
• Subjects who have Gorlins syndrome

Sponsors & Collaborators

• University of Arizona: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Mariette Marsh

  University of Arizona Human Subjects Protection Program

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 24, 2015
• Study Start: November 30, 2015
• Primary Completion: November 2, 2016
• Study Completion: November 18, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

US (1)