C71
Conditions
Interventions
Group 1: NanoTherm monotherapy
Group 2: NanoTherm combination therapy with HFSRT (hypofractionated stereotactic radiotherapy)
Group 3: HFSRT monotherapy
Sponsors
MagForce AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Radiographically (MRI) according to RANO criteria and histologically (evidence of vital tumor tissue) confirmed first progression of a histologically proven WHO grade IV glioma after primary therapy • Primary standard radiochemotherapy using TMZ followed by adjuvant TMZ chemotherapy, OR radiotherapy alone, AND at least 6 months off radiotherapy • Supratentorial tumor localization with or without prior surgery for recurrence • One tumor focus OR multiple foci in conjunction with the primary tumor or the resection cavity • Maximal volume of all contrast-enhancing tumor: 25 mL • At least one contrast-enhanced tumor residue (25 mL max.) not involving the contralateral site, and measurable according to modified Macdonald criteria • Primary irradiation dose: 54 Gy = x = 60 Gy • Age =18 years • Karnofsky performance score =60% • Life expectancy of =3 months, excluding any severe diseases interfering with the performance, evaluation, and outcome of the clinical investigation • Laboratory values as specified: ? WBC =3x 109/L ? ANC =1.5x 109/L ? Platelets =100 x 109/L ? aPTT 26 – 36 s ? Quick value 70 – 120% / INR 0.9 – 1.2 ? Hb =10.0 g/dl (=5.6 mmol/l) ? AST or ALT =3x ULN, unless attributed to anti-convulsants ? Alkaline phosphatase =2.5x ULN ? Total bilirubin =1.5x ULN ? Serum creatinine =2.0x ULN ? GFR =60 mL/min ? TSH: 0.3 mU/L < x < 3.5 mU/L • Able to undergo contrast-enhanced MRI and PET-CT • Women of childbearing potential must have a negative serum pregnancy test • Signed informed consent
Exclusion criteria
Exclusion criteria: • Irremovable metallic material within 40 cm from the rim of the magnetic field, e.g. dental fillings, crowns, implants, or staples/clips • Cardiac pacemaker, implanted defibrillator, neurostimulator, electric field supply, or other electronic implants • Hypersensitivity to the iron oxide nanoparticles or any of the ingredients of NanoTherm (aminosilanes, iron oxide, methanol) • Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s • Previous and concurrent treatment with antiangiogenic drugs • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Run-in phase: number of subjects with stable disease (SD) or better at 3 months after start of treatment Main study: mOS-2: median overall survival after start of treatment for first recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Main study: mOS-1: median overall survival from primary diagnosis OS-12: overall survival at 12 months from randomization into the study mPFS: median progression-free survival from enrollment/ randomization into the study PFS-6: PFS rate at 6 months from enrollment/ randomization into the study Tumor response: percentage of subjects with SD or better during the 1-year assessment period Quality of life (QoL): via health-related QoL scales, EORTC-QLQ-C30, version 3 and the Brain Cancer Module 20 (BCM20) questionnairesMGMT promoter methylation status: percentage of MGMT+ and MGMT- subjects and their correlation to efficacy Secondary safety endpoints: AEs, TEAEs, SAEs, laboratory parameters, KPS, physical and neurological examination, vital signs | — |
Countries
Germany
Outcome results
None listed