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Anaplastic AstrocytomaGliomstudienNCT00473408

The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas

An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by Haukeland University Hospital at 1 site in Norway.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the current trial is to explore whether the standard treatment with radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Functional MRI (DCE-MRI), Blood sample and Tumor sample
How many people
1 participants
Where
1 siteNorway
Study dates
Mar 2007to Nov 2011
Phase
Observational
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

Study population: Patients 18 years or older diagnosed and operated for high-grade astrocytoma.

Who may be able to join

  • Histologically confirmed primary high-grade astrocytoma, i.e. anaplastic astrocytoma or glioblastoma multiforme.
  • Have a WHO performance status 0-2 and be able to undergo outpatient treatment.
  • Age ≥18 years.
  • No pregnant or lactating patients can be included.
  • Patients must have radiographically documented measurable disease postoperatively. At least one tumor lesion must be unidimensionally measurable as follows:
  • Tumor lesion > 10 mm on conventional MRI scan, T1-weighted series, after intravenous (i.v.) gadolinium chelate contrast.
Show all 26Show fewer
  • All diagnostic radiology studies must be performed within 28 days prior to registration.
  • Absence of conditions making MRI scans impossible;
  • Cardiac pacemaker
  • Other ferromagnetic metal implants not authorised for use in MRI such as some types of cerebral aneurysm clips
  • Serious claustrophobia
  • Obesity (> 300 lb., 140 Kg)
  • Patients who are receiving corticosteroids have to receive stable or decreasing doses for at least 14 days before entering the trial.
  • No prior chemotherapy for high-grade astrocytoma
  • Absence of opportunistic infections making temozolomide contraindicated.
  • Minimum required laboratory data:
  • Hematology:
  • Absolute granulocytes > 1.0 x 10^9/L
  • Platelets > 100 x 10^9/L
  • Biochemistry:
  • Bilirubin < 1.5 x upper normal limit
  • INR < 1.5
  • Serum creatinine <1.5 x upper normal limit
  • Adequate cognitive function in order to give informed consent.
  • Absence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to national and local regulations.

Who cannot join

  • Lack of fulfillment of inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Dept. of Oncology & Dept. of Radiology, Haukeland University Hospital

    Bergen, Norway, Hordaland, 5021

Other trials in Norway

About this study

The purpose of the current trial is to explore whether the standard treatment with radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival.

Read the detailed description

Today's standard treatment with radiotherapy and temozolomide yields a life expectancy of 1.5-3 years in patients with high-grade astrocytomas. Thus, there is a need for further therapeutic improvements in this patient population. The purpose of the current trial is to explore whether radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival. Additionally, stem cells within malignant brain tumors is an important new area of research in this patient population, and investigations herein could contribute to identify new predictive markers and therapeutic targets.

Primary objective: To assess the vascular perfusion and permeability characteristics of high-grade astrocytomas (anaplastic astrocytoma and glioblastoma multiforme) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in patients receiving radiotherapy and temozolomide. Furthermore to assess whether therapy-induced changes in tumor perfusion is correlated with progression-free survival.

Secondary objectives:

  • Analyze circulating endothelial cells in the blood by flow cytometry to explore whether these cells can be used as an indirect estimate of angiogenesis in high-grade astrocytomas
  • Analyze tumor specimens from patients that have had their gliomas debulked before commencing therapy
  • immunostaining of the tumor vasculature to assess microvessel density
  • immunostaining for tumor stem cells
  • flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells
  • Assess progression-free survival of all patients included in the study, in order to correlate the survival data with the above tissue sampling results.
Being tested
Functional MRI (DCE-MRI), Blood sample, Tumor sample
Keywords
Glioma, DCE-MRI, Angiogenesis, Cancer stem cells, Tumor vasculature
Medical subject headings
Astrocytoma, Glioblastoma, Glioma

What participants receive

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

  • Functional MRI (DCE-MRI)Device

    MRI examination with i.v. gadolinium contrast to assess blood perfusion in remaining tumor tissue.

  • Blood sampleProcedure or surgery

    See protocol.

  • Tumor sampleProcedure or surgery

    See protocol.

Timeline

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

  1. First posted15 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionMay 2007
  4. Study completionNov 2011

Why it stopped: Moved to another country, not possible to recruit from abroad.

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473408
Sponsor's protocol ID
15437
Other IDs
REK ID: 202.06
Acronym
Gliomstudien
Status last verified
Dec 2016
First submitted
14 May 2007
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Only one patient was included before the study was terminated.

Publications

  • Cao Y, Sundgren PC, Tsien CI, Chenevert TT, Junck L. Physiologic and metabolic magnetic resonance imaging in gliomas. J Clin Oncol. 2006 Mar 10;24(8):1228-35. doi: 10.1200/JCO.2005.04.7233.

    PubMed 16525177

  • Morgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxuis S, Unger C, O'Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol. 2003 Nov 1;21(21):3955-64. doi: 10.1200/JCO.2003.08.092. Epub 2003 Sep 29.

    PubMed 14517187

  • Mancuso P, Rabascio C, Bertolini F. Strategies to investigate circulating endothelial cells in cancer. Pathophysiol Haemost Thromb. 2003 Sep-2004 Dec;33(5-6):503-6. doi: 10.1159/000083853.

    PubMed 15692268

  • Singh SK, Hawkins C, Clarke ID, Squire JA, Bayani J, Hide T, Henkelman RM, Cusimano MD, Dirks PB. Identification of human brain tumour initiating cells. Nature. 2004 Nov 18;432(7015):396-401. doi: 10.1038/nature03128.

    PubMed 15549107

Questions about this trial

What is this clinical trial studying?

An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by Haukeland University Hospital at 1 site in Norway.

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 1 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: stopped early, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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.

Are results available for this study?

The study was stopped early (reason given: Moved to another country, not possible to recruit from abroad.). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00473408, which also lists 4 linked publications.

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 6 Dec 2016.

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