Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Sta… (NCT05533242) | Clinical Trial Compass
RecruitingPhase 1
Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment
Germany15 participantsStarted 2024-01-22
Plain-language summary
Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy .
Following study objectives will be analyzed:
* Determining the Maximum Tolerated Dose (MTD)
* Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher
* Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7)
* Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7)
* Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion
Who can participate
Age range18 Years – 80 Years
SexALL
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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)…
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: Through study completion, ca 1 ½ years
2
Safety of the adjuvant radio-immunotherapy
Timeframe: Through study completion, ca 1 ½ years