Radiodynamic therapy (RDT) with Gliolan in patients with first recurrence of brain tumor

Phase 1

• Conditions: recurrence of glioblastoma; MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004631-92-DE
• Lead Sponsor: Westfälische Wilhelms-Universität Münster, C/o Universitätsklinikum Münster Geschäftsbereich Recht u. Drittmittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-06
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 33

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 <1) during the entire study (and for including a period of 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:
oral
intravaginal
transdermal
progestogen only hormonal contraception associated with inhibition of ovulation:
oral
injectable
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
IN8: Pre-menopausal* female patients with childbearing potential: a negative pregnancy test must be obtained max. 72h prior to treatment start
IN9: 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.
IN10: 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

* 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified