Clinical trial NCT03279744: A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion
Official title: A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythroleukoplakia of Mouth
Verrucous Hyperplasia of Oral Mucosa
Keywords: Oral Verrucous Hyperplasia
Oral Erythroleukoplakia
Lead sponsor: Pharma Power Biotec Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).

Detailed description: This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL).

Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows:

* Screening (within 2 weeks before dosing)
* Treatment period (up to 14 weeks)
* Safety follow-up period (within 2 weeks after final treatment)
* Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥20 years old;
2. Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
3. Patient who is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

1. Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
2. Record of previous unsuccessful treatment with photodynamic therapy;
3. Patients who have been diagnosed as having oral cancer or carcinoma in situ;
4. Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
5. Patients with impaired hepatic function (defined as AST and/or ALT \> 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine \> 1.5 mg/dL);
6. Female patient of childbearing potential who:

   * is lactating; or
   * has positive urine pregnancy test at visit -1; or
   * refuses to adopt reliable method of contraception during the study;
7. Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
8. Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.

Primary outcomes:
measure: The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total
timeFrame: 2-week safety follow-up period after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist
Study officials:
affiliation: National Taiwan University Hospital
name: Hsin-Ming Chen
role: PRINCIPAL_INVESTIGATOR
References: