Clinical trial NCT01167322: Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
Official title: Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Glioma
Keywords: NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV).

Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years.
* Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV).
* Indication for surgical tumor resection.
* Karnofsky Performance Score of 60 or higher.
* Provides signed informed consent prior to any study procedures.
* Comply with visit schedule and other rules for patients in study protocol.

Exclusion Criteria:

* Porphyria, hypersensitivity to porphyrins.
* Renal insufficiency: Creatinine 2.0 mg/dL or higher
* Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher
* Chemotherapy or other treatment for other malignant tumors
* Females who are pregnant or potentially childbearing or are breastfeeding
* Participation in other clinical trial in the previous 1 month
* Ineligible patient based on the judgement of the investigator.

Primary outcomes:
measure: Positive predictive value of tissue fluorescence
timeFrame: 1 day
Secondary outcomes:
measure: Quality of fluorescent tissue
timeFrame: 1 day
measure: Positive predictive value of tissue fluorescence in each biopsy tissue sample
timeFrame: 1 day
measure: Percentage of patients without residual tumor
timeFrame: 3 days
measure: Positive predictive value of non-fluorescent tissue at the biopsy level
timeFrame: 1 day
measure: Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).
timeFrame: 1 day
measure: Safety
timeFrame: 28 days
measure: Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）
timeFrame: 2 days
Other outcomes:
Locations:
city: Hidaka
country: Japan
facility: International Medical Center, Saitama Medical University
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
Study officials:
affiliation: Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital
name: Soichiro Shibui, MD, PhD
role: STUDY_DIRECTOR
References: