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Phase I/II dose escalation trial of radiodynamic therapy (RDT) with 5-Aminolevulinic acid in patients with first recurrence of glioblastoma
EU CTIS ID: 2024-517651-12-00
What this study is testing
To determine the maximum tolerated dose (MTD ) and safety of (neo)adjuvant RDT; maxiumun tolerated dose is determined in this study as the maximum tolerated repear RDT consisting og 5-ALA dosing and radiotherapy
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written patient consent after comprehensive information
- Adequate renal function: creatinine < 3 times above ULN; eGFR >/= 60 ml/min, Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator
- Age >/= 18 years
- Recurrence of supratentorial glioblastoma after initial resection and adjuvant radio-chemotherapy (with planned second resection cohort 0 and 1), second or third recurrences permitted
- Clinically indicated further radiotherapy
- Histological verification of recurrent glioblastoma
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 diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- 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
- Adequate renal function: creatinine < 3 times above ULN; eGFR >/= 60 ml/min, Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator
- Age >/= 18 years
- Recurrence of supratentorial glioblastoma after initial resection and adjuvant radio-chemotherapy (with planned second resection cohort 0 and 1), second or third recurrences permitted
- Clinically indicated further radiotherapy
- Histological verification of recurrent glioblastoma
- 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 after the last application of 5-ALA). Such methods include: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal - progestogen only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable - intrauterine device (IUD) - intrauterine hormone-releasing system (IUS) - bilateral tubal occlusion - vasectomised partner - male patients have to use a condom until the end of relevant systemic exposure plus a further 90-day period - 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 Gilbert’s disease bilirubin < 3 times ULN.
- 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 mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Any active infection (at the discretion of the investigator)
- Hypersensitivity against porphyrins
- Known diagnosis of porphyria
- Current participation in another clinical trial with therapeutic intervention or use of any other therapeutic interventional 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 RDT
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.