Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Disease Attributes

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

All patients will be treated with RDT. Patients are devided into cohorts which differs in the total amount and frequence of RDT.

A repetitive dose of Gliolan will be administrated in combination with radiotherapy (radiodynamic therapy)

Gliolan

Radiotherapy will be performed in combination with Gliolan administration

Radiodynamic therapy

Walter Stummer, Prof. Dr.

Hans Theodor Eich, Prof. Dr.

The investigational drug 5-ALA (known under the trade name Gliolan®) is an approved drug for the surgical removal of malignant glioma (WHO grade III and IV). In this trial, the drug is being tested outside of its actual approval as a radiosensitizer in combination with conventional radiotherapy for first-time recurrence (relapse) of malignant glioma. In this clinical trial, the investigational drug 5-ALA is being used for the first time in a multiple dose escalation regimen in combination with radiotherapy following surgical removal of a recurrent malignant glioma in humans. The investigational drug, 5-ALA, has been used as a single dose to date as a standard of care for visualization of malignant tissue in the surgical removal of gliomas.

The planned clinical trial will first and foremost investigate how well repeated administration of the investigational drug 5-ALA is tolerated in combination with radiotherapy. At the same time, the design of the trial serves to optimize this novel therapeutic procedure with regard to the frequency of administration of the investigational drug 5-ALA in combination with radiotherapy for future clinical trials.

As a secondary objective, the efficacy of additional 5-ALA administration will also be investigated.

A modified 3+3 design is used. The maximum tolerated dose of repeated RDT (consisting of 5-ALA dosing an radiotherapy) and safety will be determined in 9 cohorts.

Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor

Phase I/II Dose Escalation Trial of Radiodynamic Therapy (RDT) With 5-Aminolevulinic Acid in Patients With First Recurrence of Glioblastoma

Analytic results for concentration changes as one combined sum parameter

Analytic results for concentration changes

In the resent study we will investigate the maximum-tolerated dose (MTD) of the combination of 5-ALA and radiation. MTD is defined as the highest number of RDT that does not cause unacceptable side effects, i.e. at which no more than 1 of 6 patients suffers a dose-limiting toxicity (DLT). DLT describes side effects of a drug that are serious enough to prevent an increase of dose (NCI dictionary of cancer terms). In the present study it is defined as any ≥ Gr.3 hematological toxicity, any ≥ Gr.3 neurological toxicity and any ≥ Gr.3 non-hematological toxicity occurring during the 6 week observation period, that does not resolve to pre-treatment baseline or ≤ Gr. 2 within 3 weeks, either spontaneously or with adequate treatment.

To detect any relevant DLT the following aspects are monitored:

* Toxicological safety of repeat doses of 5-ALA
* Neurological safety of RDT
* Dermatological safety of RDT
* Assess all new AEs CTCAE grade 2 or higher

Percentage of patients who are alive 6 months after first R(D)T

Percentage of patients without tumor progression 6 months after first R(D)T in adjuvant phase

Percentage of patients without suffering any disease related event such as DLT or progression until 6 months after inclusion

analytic results of pharma-radio-dynamic tissue changes. Tissue samples collected during surgery of cohort 0 and 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor	NCT05590689	Glioblastoma	Gliolan Radiodynamic th...	18 Years - 75 Years	Universität Münster
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor	NCT05590689	Glioblastoma	Gliolan Radiodynamic th...	18 Years - 75 Years	Universität Münster

Spots Global Cancer Trial Database for radiodynamic therapy