Radioimmunotherapy using Lu-177 for glioblastoma patients after standard treatment
A Phase I Trial to Determine the Maximum Tolerated Dose and Patient-specific Dosimetry of Fractionated Intracavitary Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment
PHASE1 · University Hospital Muenster · NCT05533242
This study is testing a new type of targeted radiation therapy for glioblastoma patients after their usual treatment to see if it can help prevent the tumor from coming back.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital Muenster (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Essen and 6 other locations) |
| Trial ID | NCT05533242 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of locoregional, intracavitary radioimmunotherapy (iRIT) with Lu-177 labeled 6A10 Fab-fragments in patients with glioblastoma following standard treatment. The study aims to determine the maximum tolerated dose, assess safety through monitoring adverse events, and evaluate the absorbed radiation dose to the resection cavity and surrounding organs. Patients will receive the treatment in three fractions over a period of 12 weeks, with a focus on preventing or delaying tumor recurrence. The trial is sponsored by the University Hospital Münster and involves multiple collaborating institutions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with primary supratentorial glioblastoma who have undergone standard therapy and have stable small tumor residues.
Not a fit: Patients with extensive tumor growth or those who have not undergone the required standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly delay or prevent tumor recurrence in glioblastoma patients, improving their overall prognosis.
How similar studies have performed: While this approach is novel, similar studies in radioimmunotherapy have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written patient consent after comprehensive information * Age between 18 and 80 years * Primary supratentorial high grade glioma after standard therapy (fluorescence-guided surgery, radio-chemotherapy, concomitant + adjuvant chemotherapy), with no or stable small tumor residue (residual contrast enhancement of up to 5cm3) at earliest 6 weeks after completion of radiotherapy * Histological verification of glioblastoma and CA 12-expression of tumor cells confirmed * Karnofsky-score ≥ 60 * Volume of resection cavity 2,5-25 cm3 * Male and female patients with reproductive potential must use an approved contraceptive method * Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start * Adequate bone marrow reserve: white blood cell (WBC) count ≥3000/μl, granulocyte count \>1500/μl, platelets ≥100000/μl, hemoglobin ≥ 10 g/dl * 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. * Blood clotting: INR (=PT) and PTT within acceptable limits according to the investigator * Adequate renal function: creatinine \< 3 times above ULN; eGFR \> (or equal) 60 ml/min Exclusion Criteria: * Patient unable to undergo imaging by CT, PET or contrast-enhanced MRI for whatever reason (i.e., pacemaker) * Resection cavity with intraventricular access * Significant leakage of radioactivity into CSF spaces or ventricles * Other actively treated invasive malignancy * 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, pre-existing neurological diseases except those related to glioblastoma 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) * Previous participation in a registered clinical trial with therapeutic intervention less than 6 weeks prior to enrolment (date of informed consent) * Allergy against known constituents of study medication
Where this trial is running
Essen and 6 other locations
- Klinik für Neurochirurgie des Universitätsklinikums Essen — Essen, Germany (RECRUITING)
- Klinik für Nuklearmedizin, Strahlenklinik des Universitätsklinikums Essen — Essen, Germany (RECRUITING)
- Klinik für Allgemeine Neurochirurgie des Universitätsklinikums Köln — Köln, Germany (RECRUITING)
- Klinik für Nuklearmedizin des Universitätsklinikums Köln — Köln, Germany (RECRUITING)
- Klinik für Nuklearmedizin der Universität Münster — Münster, Germany (RECRUITING)
- Universitätsklinikum Würzburg - Neurochirurgie — Würzburg, Germany (RECRUITING)
- Universitätsklinikum Würzburg - Nuklearmedizin — Würzburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Walter Stummer, Prof. — University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie
- Study coordinator: Walter Stummer, Prof. Dr.
- Email: walter.stummer@ukmuenster.de
- Phone: 0049251/83-47472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioblastom WHO Grade 4, Carbonic anhydrase XII, Intracavitary radioimmunotherapy, Fab fragment 6A10