recurrence of glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gliolan 30 mg/ml powder for oral solutions
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 5-AMINOLEVULINIC ACID
CAS Number: 106-60-5
Concentration unit: mg/ml milligram
Sponsors
Westfälische Wilhelms-Universität Münster, C/o Universitätsklinikum Münster Geschäftsbereich Recht u. Drittmittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: IN1: Written patient consent after comprehensive information IN2: Age >/=18 years IN3: 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 resection cohort 0 and 1), second or third recurrences permitted IN4: Clinically indicated further radiotherapy as per decision of the tumor board as part of therapy for recurrence IN5: Histological verification of recurrent glioblastoma independent of methylated MGMT promotor status when alkylating chemotherapy failed at this time IN6: Karnofsky Performance Score = 60 IN7: For female and male patients and their female partners of childbearing/reproductive potential*: Willingness to apply highly effective contraception (Pearl index /= 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 puberty unless permanently sterile by bilateral orchidectomy. A woman is considered of childbearing reproductive potential (WOCBP) or as pre-menopausal, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: EX1: Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker) EX2: Pregnant and breastfeeding women EX3: 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) EX4: Any active infection (at the discretion of the investigator) EX5: Hypersensitivity against porphyrins EX6: Known diagnosis of porphyria EX7: 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 EX8: Known intolerance to study medication EX9: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: determine overall survival rate after 6 months (OSR) determine time of progression-free survival rate at 6 months (PFS) determine event-free survival rate after six months (EFS) determine pharma-radio-dynamic tissue changes in neadjuvant cohorts ;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 6 weeks after last RT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Six-months overall survival rate (OSR) • Six-months progression-free survival rate (PFS) • Six-months event-free survival rate (EFS) defined from the day of inclusion • Histological tissue changes in neoadjuvant cohorts ;Timepoint(s) of evaluation of this end point: six months defined from day of first RDT | — |
Countries
Germany
Contacts
Public ContactKlinik für Neurochirurgie
Universitätsklinikum Münster
Outcome results
None listed