A phase II/III study of high-dose, intermittent sunitinib in patients with recurrent glioblastoma multiforme: the STELLAR study

• Conditions: Glioblastoma multiforme; GBM; Brain tumor; Brain cancer; Glioma; Glioblastoom; Hersentumor; Glioom

• Registration Number: NL-OMON21711
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Signed (by the patient or legally acceptable representative) and dated Informed Consent Form

2.Histologically confirmed de novo or secondary glioblastoma with unequivocal first progression, at least 3 months off radiotherapy.

Exclusion Criteria

1.Evidence of a significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.

2.Patients with a prior (< 5 years) or concomitant second malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of high-dose sunitinib versus standard treatment with lomustine on six-month progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria.

Secondary Outcome Measures

Name	Time	Method
- To determine the effect of high-dose sunitinib on overall survival (OS 9, OS 12) in patients with recurrent GBM.<br /><br>- To assess the objective radiological response rate, using the RANO criteria.<br /><br>- To assess the safety and toxicity during treatment, using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.<br /><br>- To assess patient-oriented criteria: steroid use and health-related quality of life (reported by patients and caregivers/relatives).<br /><br>- To explore the potential value of blood markers for molecular diagnostics, disease and response monitoring. <br /><br>- To explore if MGMT promoter methylation status modulates the response to sunitinib.<br>