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A Multicenter, 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 Multicenter, 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 surgically excised. Lesions with complete response
will be surgically excised 6 months after the first or second PDT cycle. All excised tissue
specimens will be histologically 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.

- Patients with BCC arising in a previous radiated area

- 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 basal cell carcinoma [BCC] lesions must disappear completely).

Outcome Time Frame:

6 months after last treatment

Principal Investigator

Whitney Tope, MPhil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota Hospital and Clinic

Authority:

United States: Food and Drug Administration

Study ID:

PC T307/00

NCT ID:

NCT00472108

Start Date:

December 2000

Completion Date:

April 2002

Related Keywords:

  • Basal Cell Carcinoma
  • Nodular Basal Cell Carcinoma
  • Basal Cell Carcinoma
  • PDT with Metvix 160 mg/g cream
  • PDT with placebo cream
  • Histological verification
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Texas Dermatology Research InstituteDallas, Texas  75230
Northwest Cutaneous Research SpecialistsPortland, Oregon  97210
DermResearch, Inc.Austin, Texas  78759
Virginia Clinical Research, Inc.Norfolk, Virginia  23507
Clinical Research Specialists IncSanta Monica, California  90404-2115
Department of Dermatology, University of Minnesota Hospital and ClinicMinneapolis, Minnesota  55455
Department of Dermatology, Mayo Medical School, Mayo ClinicRochester, Minnesota  55905
Department of Dermatology, Roswell Park Cancer InstitueBuffalo, New York  14263