Aminolevulinic acid hydrochloride for Recurrent glioblastoma

Inclusion criteria

• {"criterion_text":"- Written patient consent after comprehensive information\n- 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\n- Age >/= 18 years\n- Recurrence of supratentorial glioblastoma after initial resection and adjuvant radio-chemotherapy (with planned second resection cohort 0 and 1), second or third recurrences permitted\n- Clinically indicated further radiotherapy\n- Histological verification of recurrent glioblastoma\n- Karnofsky Performance Score ≥ 60\n- 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\n- Pre-menopausal female patients with childbearing potential: a negative pregnancy test must be obtained max. 72h prior to treatment start\n- 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."}

Exclusion criteria

• {"criterion_text":"- Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker)\n- Pregnant and breastfeeding women\n- 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)\n- Any active infection (at the discretion of the investigator)\n- Hypersensitivity against porphyrins\n- Known diagnosis of porphyria\n- 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\n- Known intolerance to study medication\n- 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"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"MTD defined as the most frequent repetitive dose of 5-ALA during 4 weeks of fractionated conformal radiotherapy at which no more than 1 of 6 patients experiences a dose-limiting toxicity (DLT). Safety assessments include toxicological, neurological and dermatological safety of repeat 5-ALA doses and assessment of all new adverse events graded CTC AE grade 2 or higher."}

Germany

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

17-10-2024

Processing Time Days

35

Number Of Sites

1

Number Of Participants

33

Primary sponsor

Full Name

Universitaet Muenster

Organisation Type

Educational Institution

Country Of Registered Address

Germany