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New treatment option for Glioblastoma
Official title Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
ClinicalTrials.gov ID: NCT05590689
What this study is testing
What is Gliolan?
Gliolan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma.
Also referred to as 5-Aminolevulinic acid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written patient consent after comprehensive information
- Age \>/= 18 years
- Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy (e.g. radio-chemotherapy, targeted therapies, antiangiogenic...
- Clinically indicated further radiotherapy as per decision of the tumor board as part of therapy for recurrence
- Histological verification of recurrent glioblastoma independent of methylated MGMT promotor status when alkylating chemotherapy failed at this time.
You likely can't join if
- Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker)
- Pregnant and breastfeeding women
- Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled...
- Any active infection (at the discretion of the investigator)
- Hypersensitivity against porphyrins
- Known diagnosis of porphyria
See the full eligibility criteria
- Written patient consent after comprehensive information
- Age \>/= 18 years
- Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy (e.g. radio-chemotherapy, targeted therapies, antiangiogenic therapies as determined by the tumor board) (with planned second...
- Clinically indicated further radiotherapy as per decision of the tumor board as part of therapy for recurrence
- Histological verification of recurrent glioblastoma independent of methylated MGMT promotor status when alkylating chemotherapy failed at this time.
- Karnofsky Performance Score ≥ 60
- For female and male patients and their female partners of childbearing/reproductive potential(\ ): Willingness to apply highly effective contraception (Pearl index \<1) during the entire study (and for at least 6 months...
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: I. oral II. intravaginal III. transdermal
- progestogen only hormonal contraception associated with inhibition of ovulation: I. oral II. injectable III. implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- male patients have to use a condom
- sexual abstinence
- Pre-menopausal(\ ) female patients with childbearing potential: a negative pregnancy test must be obtained max. 72h prior to treatment start
- Adequate liver function: bilirubin \< 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) \< 3 times ULN. In the case of documented or suspected...
- Adequate renal function: creatinine \ /= 60 ml/min, Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator. (\ ) Definition: A man is considered of reproductive potential after...
- Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker)
- Pregnant and breastfeeding women
- Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe...
- Any active infection (at the discretion of the investigator)
- Hypersensitivity against porphyrins
- Known diagnosis of porphyria
- Participation in another clinical trial with therapeutic intervention or use of any other therapeutic treatment agent other than the standard therapy since diagnosis of glioblastoma
- Known intolerance to study medication
- Pre-treatment with other potentially phototoxic or photosensitizing substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts, products containing St. John's wort ) during the 2 weeks preceding...
The study team makes the final eligibility decision.
Where it's taking place
- Münster, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Münster, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.