Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.

JRCT ID: jRCT2021220040

Registered date:12/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: spinal cord malignant tumor
• Date of first enrollment: 12/01/2023
• Target sample size: 20
• 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
Between 22 and 26 hours after the administration of talaporfin sodium, spinal cord malignant tumor is irradiated with diode laser at a 664 nm wave- length.
The fluence is set at 27 J/cm2 with a fixed fluence rate of 150 mW/cm2.

Outcome(s)

• Primary Outcome: Survival rate after 12 month

Secondary Outcome

1) overall survival
2) Progression-free survival after 6 month
3) Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients scheduled for surgery for primary malignant spinal cord tumor removal (either total, subtotal, or partial removal, not biopsy only). Only single spinal cord tumor lesion, histopathologically suspected grade 3 or 4 in the WHO Classification of Tumors of the Central Nervous System (WHO 2016, Fourth Revised Edition) should be included. New onset or recurrent tumors are both included. In case of recurrent cases, the grade at the time of initial onset shall not be questioned.
2) In the case of new-onset cases, patients who have not undergone any curative treatment (previous biopsy surgery is not be questioned) are scheduled to receive standard radiation chemotherapy after the tumor resection. The recurrent cases indicate patients who subsequently relapse and require additional surgery despite some form of curative treatment.
3) MRI (contrast-enhanced T1-weighted image) is required to be taken within 4 weeks prior to enrollment. Patients are recruited when MRI shows the presence of a heterogeneously contrasted, borderline indistinct tumor in the spinal cord, suggesting a malignant spinal glioma of grade 3 or 4 in the WHO Classification of Tumors of the Central Nervous System (WHO 2016, Fourth Revised Edition).
4) Patients whose Brain MRI (contrast-enhanced T1-weighted image) taken within 4 weeks prior to enrollment shows no mass or dissemination requiring treatment in either the intracranial or pituitary regions.
5) MRI (contrast-enhanced T1-weighted images) taken within 4 weeks prior to enrollment showing no evidence of intrathecal dissemination or multiple spinal cord masses.
6) Patients who are at least 15 years of age at the time of consent. Gender is not specified.
7) Patients with a Karnofsky Performance Status (KPS) of 70 or higher at the time of consent, or a KPS of 50 or 60 due solely to neurological symptoms caused by the tumor.
8) Patients with adequate organ function and blood tests performed within 4 weeks prior to enrollment that meet the following criteria
WBC >=2000 /mm3, Hb >=8.0 g/dl, PLT >=80,000 /mm3, AST <=100 IU/l, ALT <=100 IU/l, Cre <=1.5 mg/dl
9) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his or her approval.

Exclude criteria

1) preexisting of sun photosensitivity or porphyria.
2) Patients with contraindication to MRI with contrast enhancement using gadolinium.
3) Patients who are participating in a clinical trial or clinical research that is different from this clinical trial (clinical trials such as for the purpose of genetic analysis or observational studies that do not involve therapeutic intervention for the target disease are acceptable).
4) Patients with serious cardiac, pulmonary, hematological, metabolic, hepatic, renal, or other complications. Their general condition is so poor that the investigators judge that they are unable to tolerate this clinical trial.
5) Patients with serious bleeding or in shock.
6) Patients with hemorrhagic diathesis.
7) IPatients with serious infections (patients with infections requiring systemic administration of antimicrobial agents, antivirals, etc. (excluding epidemic diseases and acute upper respiratory tract infection for which early recovery is expected))
8) Pregnant women or women who may be pregnant or nursing.
9) Patients who are unwilling to use an effective contraceptive method (e.g., condom, intrauterine device, oral contraceptive) to provide adequate contraception during the study period.
10) Patients with a malignant tumor other than primary malignant spinal cord tumor.
11) Any patients who are judged by the investigator or subinvestigator to be inappropriate as subjects for this clinical trial.

Related Information

• Primary Sponsor: Endo Toshiki