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

Last updated: April 26, 2012
Sponsor: Nobelpharma
Overall Status: Completed

Phase

3

Condition

Glioblastoma Multiforme

Brain Cancer

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT01167322
NPC-07-1
  • Ages 18-70
  • All Genders

Study 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

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

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/Lor 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.

Study Design

Total Participants: 45
Study Start date:
August 01, 2010
Estimated Completion Date:
December 31, 2011

Connect with a study center

  • International Medical Center, Saitama Medical University

    1397-1, Yamane, Hidaka-shi, Saitama 350-1298
    Japan

    Site Not Available

  • International Medical Center, Saitama Medical University

    Hidaka, Saitama 350-1298
    Japan

    Site Not Available

  • National Cancer Center Hospital

    5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kyorin University Hospital

    6-20-2, Shinkawa, Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

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