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

NCT00535379 | Unknown Phase 2 DMC

• 1 other identifier: EUDRACT-Nr. 2007-002142-37
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma multiforme; sunitinib; recurrent; progressive

Outcome Measures

Primary Outcomes (2)

• Progression-free survival rate at 6 months

  6 months after tumor progression

• Median time to tumor progression

  Time to tumor progression

Secondary Outcomes (2)

• Overall survival

  Time from study inclusion to death

• Overall survival rate at 12 months

  12 months after tumor progression

Study Arms (1)

1

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

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.

Also known as: SUTENT

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• The patient is active participant in another clinical trial.
• 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.

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Pfizer: collaborator

Study Sites (10)

Paracelsus Medical University

Salzburg, Salzburg, 5020, Austria

Location

LKH Feldkirch

Feldkirch, Austria

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

LNK Wagner-Jauregg

Linz, Austria

Location

Kaiser-Franz-Josef Spital Wien

Vienna, Austria

Location

Medical University Vienna

Vienna, Austria

Location

University Hospital of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

University Hospital of Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

University Hospital of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

University Hospital of Berlin

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

• Hutterer M, Nowosielski M, Haybaeck J, Embacher S, Stockhammer F, Gotwald T, Holzner B, Capper D, Preusser M, Marosi C, Oberndorfer S, Moik M, Buchroithner J, Seiz M, Tuettenberg J, Herrlinger U, Wick A, Vajkoczy P, Stockhammer G. A single-arm phase II Austrian/German multicenter trial on continuous daily sunitinib in primary glioblastoma at first recurrence (SURGE 01-07). Neuro Oncol. 2014 Jan;16(1):92-102. doi: 10.1093/neuonc/not161. Epub 2013 Dec 4.

  PMID: 24311637 DERIVED

Related Links

• Homepage of the Medical University Innsbruck

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guenther Stockhammer, MD, Prof.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 30, 2010

Record last verified: 2009-01

Locations

AU (6); DE (4)