FindTrial
Sign In

Phase I/II dose escalation trial of radiodynamic therapy (RDT) with 5-Aminolevulinic acid in patients with first recurrence of glioblastoma

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517651-12-00
Enrollment
33
Registered
2024-10-17
Start date
2022-10-28
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent glioblastoma

Brief summary

MTD is defined as the most frequent repetitive dose of 5-ALA during 4 weeks of fractionated conformal radiotherapy that does not cause unacceptable side effects, i.e. repeated dose at which no more than 1 of 6 patients suffers a dose-limiting toxicity (DLT). • Toxicological safety of repeat doses of 5-ALA • Neurological safety of RDT • Dermatological safety of RDT • Assess all new AEs CTC AE grade 2 or higher

Interventions

DRUGGliolan 30 mg/ml powder for oral solution.

Sponsors

Universitaet Muenster
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
MTD is defined as the most frequent repetitive dose of 5-ALA during 4 weeks of fractionated conformal radiotherapy that does not cause unacceptable side effects, i.e. repeated dose at which no more than 1 of 6 patients suffers a dose-limiting toxicity (DLT). • Toxicological safety of repeat doses of 5-ALA • Neurological safety of RDT • Dermatological safety of RDT • Assess all new AEs CTC AE grade 2 or higher—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026