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Recurrent Malignant GliomaPhase 2AVIRMA01-09NCT01144988

Avastin / Irinotecan in Patients With Recurrent or Progressive Malignant Glioma

A Phase 2 study testing Bevacizumab / Irinotecan in people with Recurrent Malignant Glioma, run by Medical University Innsbruck at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite advances in multimodal treatment including surgery, radiation and chemotherapy, most patients have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Malignant Glioma
What is being tested?
Bevacizumab / Irinotecan
How many people
35 participants
Where
2 sitesAustria
Study dates
Mar 2010to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients present with a first or second tumor recurrence / progression of a histological confirmed supratentorial malignant glioma WHO Grade III-IV (Classification following WHO criteria).
  • Patients with surgical resection of tumor recurrence / progression: Following standard therapy(first recurrence) or standard therapy / second line chemotherapy (second recurrence, excepting antiangiogenic approaches) patients must have evidence of further tumor progression measured by standard MRI sequences (MacDonald criteria). If possible, patients may have prior surgical resection of the tumor progression and will be eligible if the following conditions apply:
  • Patients must have recovered from the effects of surgery
  • To adequately asses the malignant glioma before surgery and the extent of residual disease postoperatively, two MRIs scans have to be performed:
  • A first standard MRI scan has to be done within 1 week before surgery to document a progressed or recurrent malignant glioma.
  • A second standard / functional MRI scan has to be done between 24 and 48 hours after surgery to document the postoperative malignant glioma (Baseline MRI scan).
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  • FET- / FLT-PET scans have to be done within 2 weeks after surgery to document the postoperative malignant glioma (Baseline PET scans).
  • Patients without surgical resection of the tumor recurrence / progression: Patients must have evidence of tumor progression measured by standard MRI sequences (MacDonald criteria).
  • Additional functional MRI sequences have to be done within 1 week prior to study enrollment.
  • FET- / FLT-PET scans have to be done within 2 weeks after surgery to document the postoperative malignant glioma (Baseline PET scans).
  • Resolution of all acute toxic effects of prior therapy to grade ≤ 1 (except alopecia)
  • Patients must have an ECOG performance status of 0-2
  • Patients must be ≥ 18 years and ≤ 80 years of age, with a life expectancy of greater than 8 weeks
  • Patients must have adequate organ function as defined by the following criteria:
  • Bone Marrow Reserve
  • Platelets ≥ 75.000/μL
  • Absolute Neutrophil Count ≥ 1500/μL
  • Hemoglobin ≥ 10.0 g/dL Blood Coagulation
  • aPTT ≤ 1.5 times upper limit of normal (ULN) Hepatic Function
  • ASAT and ALAT ≤ 2.5 times ULN
  • ALP ≤ 2.5 times ULN
  • Total SERUM Bilirubin < 1.5 times ULN Renal Function
  • SERUM Creatinine ≤ 1.5 times ULN Metabolism
  • SERUM Albumin ≥ 3.0 g/dL All tests must be performed ≤ 3 days prior to study enrollment. Eligibility for hemoglobin count may be reached by transfusion.
  • Signed and dated informed consent document by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment.
  • Willingness and ability of the patient to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • The patient is active participant in another clinical trial, which investigates substances with antiangiogenic effectiveness
  • Exclusion of patients in the event of
  • surgery of a recurrent / progressed malignant glioma within 2 weeks prior to study enrollment
  • chemotherapy (Standard therapy o Second Line Chemotherapy) within 2 weeks prior to study enrollment
  • radiation therapy (Standard therapy) within4 weeks to study enrollment
  • evidence in baseline MRI of intratumoral or peritumoral hemorrhage deemed clinically significant by the treating physician (area of hemorrhage > 25% of tumor area)
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  • Significant Co-Morbidities within 12 months prior to study enrollment
  • myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure
  • cerebrovascular accident including transient ischemic attack
  • Significant Co-Morbidities at Baseline Evaluation
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
  • Pulmonary embolism within 4 weeks before study enrollment
  • A known HIV (human immunodeficiency virus) or Hepatitis B/C infection or severe acute infection
  • Anticoagulation: Current treatment with therapeutic doses of Marcoumar / Sintrom excluding thrombosis prophylaxis with low dose Heparin
  • Pregnancy, Breastfeeding and Non-Contraception
  • Female patients who are pregnant or nursing
  • Patients who are sexually active and unwilling or unable to use a medically acceptable method of contraception during the trial
  • Evidence of increased intracranial pressure
  • midline shift > 5 mm
  • headache, distinct nausea and vomiting
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart excess risk associated with study participation or study drug administration, or which would make the patient inappropriate for entry into this study. The decision to enroll the patient in this study is in the judgment of the investigator.

Trial locations and contacts

2 sites in 1 country.

Guenther Stockhammer, MD, Prof. contact

guenther.stockhammer@i-med.ac.at

Markus Hutterer, MD contact

m.hutterer@salk.at

Austria2 sites, 2 recruiting

  • Medical University Innsbruck, Department for Neurology

    Innsbruck, A-6020

    Guenther Stockhammer, MD, Prof., guenther.stockhammer@i-med.ac.at

    Martha Nowosielski, MD, Martha.Nowosielski@i-med.ac.at

    Recruiting

  • Paracelsus Medical University, Christian Doppler Klinik

    Salzburg, Austria, 5020

    Markus Hutterer, MD, m.hutterer@salk.at

    Stefan Golaszewski, MD

    Recruiting

Other trials in Austria

About this study

Official title: An Academic Prospective Single-arm Phase II Clinical Trial for Evaluation of Advanced Functional Neuroimaging Techniques and Molecular Markers in the Course of Anti-angiogenic Therapies in Malignant Gliomas

Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite advances in multimodal treatment including surgery, radiation and chemotherapy, most patients have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005).

A major reason for the aggressiveness of malignant glioma is a pronounced tumor neovascularization, mainly driven by the vascular endothelial growth factor (VEGF) and its receptors. The therapeutic monoclonal antibody Bevacizumab (Avastin®) inhibits the VEGF pathway by binding the VEGF ligand. In Magnetic Resonance Imaging (MRI) this treatment reduces contrast enhancement by restoring both, the blood-brain-barrier and the destabilized vessel integrity. Furthermore, it raises the sensitivity of co-administered chemotherapeutics such as Irinotecan. In conclusion, anti-angiogenic therapy leads to the problem that the routinely used MRI techniques cannot distinguish anti-vascular effects from true anti-tumor effects.

The study hypothesis of the clinical trial part is that in 35% of malignant glioma patients Avastin / Irinotecan chemotherapy results in objective tumor responses assessed by standard / functional MRI and FET- /FLT-PET neuroimaging. The study hypothesis for the translational study part is that the expression of the molecular targets of Avastin and Irinotecan in malignant glioma tissue ( = tumor and vascular cells) are predictive for Avastin / Irinotecan therapy induced treatment response measured by functional MRI and FET- / FLT-PET imaging.

Being tested
Bevacizumab / Irinotecan
Keywords
Recurrent Malignant Glioma, Bevacizumab / Irinotecan, Functional MR Imaging, Metabolic Imaging (FET/FLT-PET)
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab / IrinotecanDrug

    Bevacizumab (10mg/kg KG) Irinotecan (125 mg/ m2 or 340 mg/m2 depending on usage of EIAED)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the objective tumor response criteria (RR, ORR, ORD) assessed by Standard MRI and FET-/FLT-PET during Avastin / Irinotecan chemotherapy.

    Measured: three years

Secondary outcomes (1)

  1. Evaluation of the predictive / prognostic value of the VEGF pathway and tumor cell proliferation rate in tumor and vascular cells of malignant gliomas treated with Avastin / Irinotecan Chemotherapy

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2013 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144988
Sponsor's protocol ID
EUDRACT-Nr: 2009-015036-15
Acronym
AVIRMA01-09
Status last verified
Aug 2011
First submitted
15 Jun 2010
Last updated
2 Aug 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab / Irinotecan in people with Recurrent Malignant Glioma, run by Medical University Innsbruck at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guenther Stockhammer, MD, Prof. (guenther.stockhammer@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the objective tumor response criteria (RR, ORR, ORD) assessed by Standard MRI and FET-/FLT-PET during Avastin / Irinotecan chemotherapy. (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.

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