Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405CIN for patients with cervical intraepithlial neoplasia

JRCT ID: jRCT2041190087

Registered date:26/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cervical intraepithelial neoplasia
• Date of first enrollment: 02/03/2020
• Target sample size: 75
• Study type: Interventional

Intervention(s)

1.Investigational agent administration
One hundred milligrams of talaporfin sodium are dissolved in 4 mL of saline, and a 40 mg/m2 dose is slowly injected intravenously.
2. Investigational equipment and laser irradiation method
Four to 6 hours after administration of talaporfin sodium, the cervical and endocervical lesions are irradiated with diode laser at a 664 nm wave- length.
The fluence is set at 100 J/cm2 with a fixed fluence rate of 150 mW/cm2.
The operator uses a direct shot probe to irradiate cervical lesion and a side shot probe to irradiate endocervical lesion.

Outcome(s)

• Primary Outcome: Complete response

Secondary Outcome

the clearance rate of HPV
the clearance rate of HPV 12 weeks after PDT
recurrence-free interval, recurrence rate
overall survival
preterm birth rate, threatened premature delivery rate, and changes in cervical length

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1)Female patients over 20 years old when obtaining consent
2)The subjects were patients who were diagnosed with CIN2 or CIN3 based on cervical cytology and histology findings and whose lesions were confirmed macroscopically by colposcopy.
3) Patients who do not wish to receive treatment other than PDT including
4) Eastern Cooperative Oncology Group performance status; 0-1
5) Patients with adequate bone marrow function
1.White blood cell count ; >3,000/mm3
2.Platelet count ; >100,000/mm3
3.Both alanine aminotransferase and aspartate aminotransferase ; Less than twice the facility standard
4.Serum total bilirubin level ; <2.0 mg/dL
5.Blood urea nitrogen and serum creatinine; Less than 1.5 times the facility standard
6) Provision of written informed consent.

Exclude criteria

1) patients with AGC (atypical glandular cells), AIS (adenocarcinoma in situ), invasive squamous cell carcinoma or other cervical malignant tumor
2) patients diagnosed with UCF (Unsatisfactory colposcopic findings) or TZ type3 by colposcopy
3) patients with other cancer
4) significant cardiovascular diseases (uncontrolled hypertension, myocardial infarction, unstable angina, congestive heart failure), uncontrolled diabetes mellitus, or severe liver cirrhosis, severe renal failure
5) preexisting of sun photosensitivity
6) porphyria
7) history of treatment with PDT using porfimer sodium or talaporfin sodium
8) pregnant or nursed women, and woman want to pregnancy within this trial period
9) unwillingness to use of contraception
10) participating in other clinical trials or within 3 months after retirement of prior clinical trial
11) judged by investigator that enrollment was inappropriate for the patient

Related Information

• Primary Sponsor: Murakami Hirotake
• Source(s) of Monetary Support: Meiji Seika Pharma Co., Ltd.