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Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NPC-07 for oral administration
Sponsored by
Nobelpharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Glioma focused on measuring NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • International Medical Center, Saitama Medical University
  • National Cancer Center Hospital
  • Kyorin University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPC-07

Arm Description

Single administration of NPC-07 at a dose of 20mg/kg body weight

Outcomes

Primary Outcome Measures

Positive predictive value of tissue fluorescence
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.

Secondary Outcome Measures

Quality of fluorescent tissue
Quality of fluorescent tissue by the judgement of the investigator
Positive predictive value of tissue fluorescence in each biopsy tissue sample
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
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
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).
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
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）
Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）

Full Information

First Posted
July 16, 2010
Last Updated
April 26, 2012
Sponsor
Nobelpharma
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1. Study Identification

Unique Protocol Identification Number
NCT01167322
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPC-07
Arm Type
Experimental
Arm Description
Single administration of NPC-07 at a dose of 20mg/kg body weight
Intervention Type
Drug
Intervention Name(s)
NPC-07 for oral administration
Other Intervention Name(s)
5-ALA, 5-aminolevulic acid hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive predictive value of tissue fluorescence
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Quality of fluorescent tissue
Description
Quality of fluorescent tissue by the judgement of the investigator
Time Frame
1 day
Title
Positive predictive value of tissue fluorescence in each biopsy tissue sample
Description
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.
Time Frame
1 day
Title
Percentage of patients without residual tumor
Description
Percentage of patients without residual tumor in the MRI within 72 hours after surgery
Time Frame
3 days
Title
Positive predictive value of non-fluorescent tissue at the biopsy level
Description
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).
Time Frame
1 day
Title
Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).
Description
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).
Time Frame
1 day
Title
Safety
Description
AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2
Time Frame
28 days
Title
Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）
Description
Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soichiro Shibui, MD, PhD
Organizational Affiliation
Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital
Official's Role
Study Director
Facility Information:
Facility Name
International Medical Center, Saitama Medical University
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan

12. IPD Sharing Statement

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Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas

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