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

NCT01167322 | Completed Phase 3 DMC

• 1 other identifier: NPC-07-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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

Keywords

NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (7)

• Quality of fluorescent tissue

  1 day

• Positive predictive value of tissue fluorescence in each biopsy tissue sample

  1 day

• Percentage of patients without residual tumor

  3 days

• Positive predictive value of non-fluorescent tissue at the biopsy level

  1 day

• Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).

  1 day

Study Arms (1)

NPC-07

EXPERIMENTAL

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

Drug: NPC-07 for oral administration

Interventions

NPC-07 for oral administration 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.

Also known as: 5-ALA, 5-aminolevulic acid hydrochloride

NPC-07

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (3)

International Medical Center, Saitama Medical University

Hidaka, Saitama, 350-1298, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Glioma

Interventions

Administration, Oral

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Soichiro Shibui, MD, PhD

  Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 22, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

JP (3)