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Clinical Trials/EUCTR2015-002727-25-DE
EUCTR2015-002727-25-DE
Active, not recruiting
Phase 1

Controlled clinical trial to evaluate the safety and efficacy of stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan®) in recurrent glioblastoma - NOA11

niversitätsklinikum Münster0 sites106 target enrollmentMarch 16, 2017
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DrugsGliolan 30 mg/ml powder for oral solution

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitätsklinikum Münster
Enrollment
106
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 16, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Münster

Eligibility Criteria

Inclusion Criteria

  • •1\. Written informed consent
  • •2\. Age 18 \- 75 years
  • •3\. Karnofsky Performance Score (KPS) of \=60 %
  • •4\. Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular lobe and diencephalon. Tumors in the brain stem are excluded.
  • •First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Recurrent tumor must not necessarily be in the same location as primary tumor.
  • •5\. Single or single progressive contrast\-enhancing lesion on MRI, largest diameter not more than 2\.5 cm
  • •6\. For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index \<1\) during the entire study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. Multifocal disease in more than 2 locations
  • •2\. Patients with significant non enhancing tumor portions
  • •3\. Previous treatment of recurrence
  • •4\. Other malignant disease except basalioma
  • •5\. Hypersensitivity against porphyrins or Gliolan® or FEP (Fluorethylenpropylen)
  • •6\. Porphyria
  • •7\. HIV infection, active Hepatitis B or C infection
  • •8\. Bone marrow reserve:
  • •white blood cell (WBC) count \<2000/µl,
  • •platelets \<100000/µl,

Outcomes

Primary Outcomes

Not specified

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