Know Cancer

or
forgot password

A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma.


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

Thank you

Trial Information

A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma.


A patient will be randomised to PDT with Metvix® cream or PDT with placebo cream. All
eligible BCC lesions within a patient will get the same treatment. All patients will get two
consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no
clinical response or progression will be surgically excised. Lesions with partial response
(50% or greater reduction on lesion area) will be re-treated, if they do not show complete
response three months later they will be surgical excised. Lesions with complete response
will be surgically excised 6 months after the first or second PDT cycle. All excised tissue
specimens will be histological examined.


Inclusion Criteria:



A patient with primary, nodular BCC lesion(s) suitable for entry is defined as a patient
with

- Clinically diagnosed primary nodular BCC lesion(s)

- Histologically confirmed diagnosis of BCC

- BCC lesions suitable for simple excision surgery.

- Males or females above 18 years of age.

- Written informed consent

Exclusion Criteria:

A patient that is ineligible for inclusion is a patient fulfilling any of the following
criteria:

- Patient with porphyria.

- Patient with Gorlin's syndrome.

- Patient with Xeroderma pigmentosum

- Patients concurrently receiving immunosuppressive medication

- Patients with a history of arsenic exposure.

- Known allergy to Metvix®, a similar PDT compound or excipients of the cream

- Participation in other clinical studies either concurrently or within the last 30
days.

- Pregnant or breast-feeding: All women of child-bearing potential must use adequate
contraception (e.g. barrier methods, oral contraceptives or intrauterine device)
during the treatment period and one month thereafter. In addition, they must have a
negative pregnancy test prior to treatment.

- Conditions associated with a risk of poor protocol compliance.

Lesion Exclusion Criteria:

- A nodular BCC lesion in periorbital area, ears and nasolabial fold.

- A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in
face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on
truncus.

- Pigmented nodular BCC lesion(s)

- Morpheaform nodular BCC lesion(s).

- Infiltrating nodular BCC lesion(s).

- Prior treatment of the BCC lesion(s).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely).

Outcome Time Frame:

6 months after last treatment

Principal Investigator

Peter Foley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Dermatology, St. Vincent's Hospital Melbourne

Authority:

United States: Food and Drug Administration

Study ID:

PC T308/00

NCT ID:

NCT00472043

Start Date:

October 2000

Completion Date:

September 2002

Related Keywords:

  • Basal Cell Carcinoma
  • Nodular Basal Cell Carcinoma
  • Basal Cell Carcinoma
  • Photodynamic therapy (PDT)
  • Metvix
  • Histological verification
  • PDT with Metvix cream
  • PDT with Placebo cream
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location