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

NCT ID: NCT01167322

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Malignant Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NPC-07

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

Group Type: EXPERIMENTAL

NPC-07 for oral administration

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

5-ALA, 5-aminolevulic acid hydrochloride

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soichiro Shibui, MD, PhD

Role: STUDY_DIRECTOR

Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital

Locations

International Medical Center, Saitama Medical University

Hidaka, Saitama, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Countries

Japan

Other Identifiers

NPC-07-1

Identifier Type: -

Identifier Source: org_study_id