Trial document




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  DRKS00005476

Trial Description

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Title

MF 1001: Open-label, randomized, controlled study to determine the efficacy and safety of NanoTherm® monotherapy and NanoTherm® in combination with radiotherapy versus radiotherapy alone in recurrent / progressive glioblastoma.

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Trial Acronym

MF 1001

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URL of the Trial

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Brief Summary in Lay Language

MF 1001 is a study to investigate NanoTherm Therapy® in patients with recurrent glioblastoma, a malignant brain tumor.

What is the NanoTherm Therapy?
The NanoTherm Therapy generates heat inside the tumor. It consists of 5 medical devices: iron oxide nanoparticles (NanoTherm®), the NanoActivator® to generate an alternating magnetic field, a temperature monitor and a catheter for actual temperature measurement, and a software (NanoPlan®), which simulates the temperature distribution in the treatment area.
During the first step of the therapy, the iron oxide nanoparticles are injected directly into the tumor in a small surgery. Afterwards, the nanoparticles are activated in an alternating magnetic field (NanoActivator). The activated nanoparticles produce heat, which either kills or sensitizes the tumor cells for a concurrent radiotherapy or chemotherapy. In this study, a radiotherapy is given in parallel.
In a previous clinical study, the NanoTherm Therapy showed a favorable safety profile with a prolonged overall survival rate in combination with radiation therapy. Based on this study, the NanoTherm Therapy was CE-certified all over Europe.

Why this study is undertaken?
The objective of this study is to validate the safety and efficacy of the NanoTherm Therapy in recurrent glioblastoma. In up to 269 patients, it is investigated whether the NanoTherm monotherapy or the combination of NanoTherm Therapy and an optimized radiation therapy are equally effective or even more effective than the optimized radiation therapy alone. Moreover, two components of the therapy are specifically investigated: the nanoparticles in a higher concentration and a new thermometry catheter.
The scope of this trial is to develop a more effective tumor therapy and accomplish a longer survival time and less side effects with the NanoTherm Therapy alone or in combination with radiotherapy.

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Brief Summary in Scientific Language

This clinical investigation is an open-label, controlled, multicenter study in patients with recurrent progressive glioblastoma. In a run-in phase, the efficacy and safety of NanoTherm monotherapy is evaluated. In the following main study, the efficacy and safety of NanoTherm monotherapy (when effective in the run-in phase) and NanoTherm Therapy in combination with a hypofractionated stereotactic radiotherapy (HFSRT) is investigated versus the HFSRT monotherapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005476
  •   2013/11/27
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  •   no
  •   Approved
  •   2012-475-f-M, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   CIV-12-10-008944 
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Health Condition or Problem studied

  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

  •   NanoTherm monotherapy
  •   NanoTherm combination therapy with HFSRT (hypofractionated stereotactic radiotherapy)
  •   HFSRT monotherapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/25
  •   269
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • MagForce AG
    • Max-Planck-Straße 3
    • 12489  Berlin
    • Germany
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    • MagForce AG
    • Mr.  Dr.  Claus  Thielert 
    • Bunsenstrasse 7
    • 82152  Martinsried
    • Germany
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    • Clinical Project Management, MF 1001, MagForce AG
    • Bunsenstrasse 7
    • 82152  Martinsried
    • Germany
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Sources of Monetary or Material Support

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    • MagForce AG
    • Max-Planck-Straße 3
    • 12489  Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2015/03/05
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Trial Publications, Results and other Documents

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