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

NCT00473408 | Terminated

• 2 other identifiers: 15437REK ID: 202.06
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival.

Conditions

Anaplastic Astrocytoma; Glioblastoma Multiforme; Tumor Angiogenesis

Keywords

Glioma; DCE-MRI; Angiogenesis; Cancer stem cells; Tumor vasculature

Interventions

Functional MRI (DCE-MRI) DEVICE

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

Blood sample PROCEDURE

See protocol.

Tumor sample PROCEDURE

See protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

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

Bergen, Norway, Hordaland, 5021, Norway

Location

Related Publications (4)

• 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.

  PMID: 16525177 BACKGROUND

• 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.

  PMID: 14517187 BACKGROUND

• 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.

  PMID: 15692268 BACKGROUND

• 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.

  PMID: 15549107 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples and blood samples are collected and frozen for future analysis for tumor vascularization and tumor stem cells.

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Glioma

Interventions

Magnetic Resonance Imaging; Dynamic Contrast Enhanced Magnetic Resonance Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hans Petter Eikesdal, MD PhD

  Institute of Biomedicine, University of Bergen, Jonas Lies vei 91, 5009 Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: November 1, 2011
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)