SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme (SURGE01-07)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Medical University Innsbruck.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00535379
First received: September 25, 2007
Last updated: August 27, 2010
Last verified: January 2009
  Purpose

Clinical Part:

The objective of this study is to determine the efficacy and safety of SUTENT in patients with recurrent or progressive glioblastoma multiforme.Patients with tissue based diagnosis of intracranial glioblastoma multiforme, above 18 years of age and of both genders, who have a first tumor recurrence or progress after surgery, radiation- and chemotherapy will be included. The hypothesis is that SUTENT will significantly increase the progression free survival rate at 6 months in the study population.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme An Academic Prospective Single-arm Phase II Clinical Trial Including Ranslational Research Studies

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Progression-free survival rate at 6 months [ Time Frame: 6 months after tumor progression ] [ Designated as safety issue: No ]
  • Median time to tumor progression [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Time from study inclusion to death ] [ Designated as safety issue: No ]
  • Overall survival rate at 12 months [ Time Frame: 12 months after tumor progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sunitinib
Patients will receive SUTENT 37.5mg (3 x 12.5mg capsules) PO daily in the morning after breakfast. After 2 weeks without treatment-related adverse events grade ≥ 2 (ECOG common toxicity criteria: refer to Protocol Attachment A.4) a SUTENT dose escalation to 50mg (4 x 12.5mg capsules) PO daily has to be performed. Treatment will continue until patients develop progression of disease or until unacceptable adverse events occur.
Other Name: SUTENT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients present with a first recurrence or first progression of a histological confirmed primary supratentorial glioblastoma multiforme WHO Grade IV (Classification following WHO criteria).
  • Patients with surgical resection of first tumor progression: Following standard therapy patients must have evidence of first tumor progression. In general, patients may have undergone prior surgical resection of the first tumor progression and will be eligible if the following conditions apply:
  • Patients must have recovered from the effects of surgery
  • To adequately asses the GBM before surgery and the extent of residual disease postoperatively, two MRIs scans have to be performed:
  • The first MRI scan within 2 weeks before surgery to document a progressed or recurrent GBM. The second MRI scan within 48 hours after surgery.
  • Patients without surgical resection of first tumor progression:
  • Patients must have evidence of first tumor progression following standard therapy as measured by a baseline MRI within 2 weeks prior to study enrollment (Macdonald criteria: i.e. tumor growth > 25% or new lesion).
  • 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 ≤ 75 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 (ANC) ≥ 1500/μL
  • Hemoglobin ≥ 10.0 g/dL Blood Coagulation - aPTT ≤ 1.5 times upper limit of normal (ULN) Hepatic Function - ASAT and ALAT ≤ 1.5 times ULN
  • ALP ≤ 2.5 times ULN
  • Total Serum Bilirubin < 1 times ULN Renal Function - Serum Creatinine ≤ 1.5 times ULN Metabolism - Serum Albumin ≥ 3.0 g/dL Heart Function - Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by transthoracic echocardiogram ECHO) 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

Exclusion Criteria:

  • The patient is active participant in another clinical trial.
  • Exclusion of patients in the event of

    • surgery for recurrence/progression within 1 week prior to study enrollment
    • chemotherapy within 4 weeks prior to study enrollment
    • treatment with more than one chemotherapy regime
    • radiation therapy within 8 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)
  • Significant Co-Morbidities within 12 months prior to study enrollment

    • myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure
    • pulmonary embolus
    • cerebro-vascular accident including TIA (transient ischemic attack)
  • Significant Co-Morbidities at Baseline Evaluation

    • Clinically significant ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 470 ms measured by electrocardiogram (ECG)
    • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
    • 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.
  • Antiepileptic Drugs: Concurrent use of EIADs within 2 weeks of study enrollment (patients must discontinue EIAD treatment ≥ 14 days prior to study enrollment)
  • 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
    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535379

Locations
Austria
LKH Feldkirch
Feldkirch, Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
LNK Wagner-Jauregg
Linz, Austria
Paracelsus Medical University
Salzburg, Austria, 5020
Medical University Vienna
Vienna, Austria
Kaiser-Franz-Josef Spital Wien
Wien, Austria
Germany
University Hospital of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
University Hospital of Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
University Hospital of Bonn
Bonn, Nordrhein-Westfalen, Germany, 53105
University Hospital of Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Medical University Innsbruck
Pfizer
Investigators
Principal Investigator: Guenther Stockhammer, MD, Prof. Medical University Innsbruck
  More Information

Additional Information:
No publications provided by Medical University Innsbruck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University Innsbruck, Department of Neurology
ClinicalTrials.gov Identifier: NCT00535379     History of Changes
Other Study ID Numbers: EUDRACT-Nr. 2007-002142-37
Study First Received: September 25, 2007
Last Updated: August 27, 2010
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medical University Innsbruck:
glioblastoma multiforme
sunitinib
recurrent
progressive

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014