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An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma


Prospective, open, multicenter study. The high risk BCC lesions will be treated with Metvix
cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6
months prior to treatment. The patients will receive one or two treatment cycles each
consisting of two Metvix PDT treatments 7 days apart (Lesion that show non-complete response
at 3 months will have a second PDT treatment cycle).

The primary end-point will be the histologically confirmed complete response rate within a
patient (No BCC cells in the biopsy taken 3 months after the last treatment).

Secondary endpoints are safety evaluation during the first 13 weeks or 6 months (if two
treatment cycles) after the first Metvix treatment, cosmetic outcome and recurrence rates
12, 24, 35, 48 and 60 months after the first Metvix treatment.


Inclusion Criteria:



- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)

- Males or females above 18 years of age.

- Written informed consent. AND

Patients with high risk of surgical complications due to:

- Anticoagulant medication or bleeding disorders

- Cardiac risk factors

- Anaesthetic contraindications

- Poor surgical compliance because of patient refusal, dementia, or inability to
perform wound care.

OR

• Patients with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:

A large BCC lesion with the largest diameter:

- Equal to or greater than 15 mm on extremities, except below the knees, where largest
diameter should be equal to or greater than 10 mm

- Equal to or greater than 20 mm on the trunk

- Equal to or greater than 15 mm in the face, or A lesion in the mid-face region
(H-zone according to Swanson) or on the ear In patients with more then 6 eligible
lesions, the 6 lesions to be treated will be randomly chosen.

Exclusion Criteria:

- Prior treatment of the lesion within 4 weeks.

- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by
histology. A mixed nodular/morpheaform lesion which is not highly infiltrated
(clinically) may be included.

- Patient with porphyria.

- Pigmented lesions.

- Known allergy to Metvix® or a similar compound.

- Participation in another clinical study either concurrently or within the last 30
days

- Patient with Gorlin's syndrome.

- Patient with Xeroderma pigmentosum

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative pregnancy test and use contraception during the treatments and for at least
one month thereafter).

- Conditions associated with a risk of poor protocol compliance.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary end-point will be the histologically confirmed complete response rate within a patient (No BCC cells in the biopsy taken 3 months after the last treatment).

Outcome Time Frame:

3 months after last treatment

Principal Investigator

Carl Vinciullo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dermatology Surgery & Laser Centre, Perth

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PC T310/00

NCT ID:

NCT00473343

Start Date:

September 2000

Completion Date:

June 2006

Related Keywords:

  • Basal Cell Carcinoma
  • Photodynamic therapy (PDT)
  • PDT with Metvix cream
  • "High risk" BCC
  • Basal Cell carcinoma
  • Histologically confirmed complete response
  • Carcinoma
  • Carcinoma, Basal Cell

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