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Lomustine

Sunitinib

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Alkylating Agents

Patients in this experimental arm will receive sunitinib in a high-dose, intermittent schedule.

Patients in this control arm will receive lomustine, currently used as second-line treatment in the case of recurrence.

Sunitinib, 300 mg administered orally in a weekly schedule.

Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.

Myra E Van Linde, MD

Jorien Janssen, MD

Annemiek ME Walenkamp, MD PhD

Chantal Driessen, MD, PhD

In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule, will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic properties, inhibit gliomagenesis by inhibition of multiple kinases.

Study design: Multicenter, phase II/III, randomized clinical trial with high-dose sunitinib versus lomustine (CCNU) in patients with recurrent GBM.

Hypothesis: Sunitinib, when given in a high-dose, intermittent schedule, may exhibit improved efficacy in patients with recurrent GBM with an acceptable toxicity profile, compared to lomustine.

Study population: Adult patients with recurrent GBM.

Primary objective:

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

Secondary objectives:

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

Treatment: After randomization, 100 patients will be divided equally over two treatment groups and will receive:

* Group 1 (experimental arm): Sunitinib, 700 mg administered orally every 2 weeks.
* Group 2 (control arm): Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.

Disease will be assessed by MRI according to an uniform neuro-oncology protocol every 6 weeks for the first 6 months and every 12 weeks until documented progression. Safety profile of both treatment strategies will be assessed separately for each cycle of therapy and every 12 weeks after the end of treatment if adverse effects have not resolved or are newly emerging. Furthermore, quality of life assessment takes place every 6 weeks using questionnaires.

A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme

A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme: the STELLAR Study

Response will be assessed according to the RANO criteria.

At the end of the study, after 36 months, the number of participants with adverse events that are related to both treatments will be assessed and compared.

Steroid use will be documented at every treatment cycle as an objective parameter for HRQoL. Furthermore, HRQoL will also be measured via EORTC questionnaires, which will be filled in by the participants every 6 weeks BEFORE their MRI.

The five specific time points during study treatment are: (1) at baseline; (2) at the first outpatient visit; (3) after two weeks of treatment; (4) at the first response evaluation (first MRI); and (5) at the time of progression.

Previously obtained resection or biopsy material from the first-line treatment of these participants will be requested at the time of inclusion and used to determine the MGMT methylation status. After the End of Study (after 36 months) the MGMT promoter methylation status will be correlated with the response to treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme	NCT03025893	Glioblastoma Mu... Glioblastoma, A... Glioblastoma Recurrent Brain... GBM	Sunitinib Lomustine	18 Years -	Amsterdam UMC, location VUmc
A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme	NCT03025893	Glioblastoma Mu... Glioblastoma, A... Glioblastoma Recurrent Brain... GBM	Sunitinib Lomustine	18 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for intermittent

Every month we try and update this database with for intermittent cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.