Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
|ClinicalTrials.gov Identifier: NCT01167322|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : April 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: NPC-07 for oral administration||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2010|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Single administration of NPC-07 at a dose of 20mg/kg body weight
Drug: NPC-07 for oral administration
NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.
Other Name: 5-ALA, 5-aminolevulic acid hydrochloride
- Positive predictive value of tissue fluorescence [ Time Frame: 1 day ]Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.
- Quality of fluorescent tissue [ Time Frame: 1 day ]Quality of fluorescent tissue by the judgement of the investigator
- Positive predictive value of tissue fluorescence in each biopsy tissue sample [ Time Frame: 1 day ]Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among all biopsies taken from areas of strong and weak fluorescence.
- Percentage of patients without residual tumor [ Time Frame: 3 days ]Percentage of patients without residual tumor in the MRI within 72 hours after surgery
- Positive predictive value of non-fluorescent tissue at the biopsy level [ Time Frame: 1 day ]Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among the non-fluorescent tissue adjacent to fluorescent tissue areas and the tumor distant cortex with respect to tumor (if available).
- Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available). [ Time Frame: 1 day ]Sensitivity as percentage of actual positives(True positive fraction/True positive fraction + False negative fraction)and specificity as percentage of actual negatives of fluorescence detection (True negative fraction/False positive fraction + True negative fraction) at the biopsy level (if available).
- Safety [ Time Frame: 28 days ]AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2
- Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2） [ Time Frame: 2 days ]Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167322
|International Medical Center, Saitama Medical University|
|Hidaka, Saitama, Japan, 350-1298|
|National Cancer Center Hospital|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Kyorin University Hospital|
|Mitaka, Tokyo, Japan, 181-8611|
|Study Director:||Soichiro Shibui, MD, PhD||Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital|