The Addition of Chloroquine to Chemoradiation for Glioblastoma,

Launched by MAASTRICHT RADIATION ONCOLOGY · Apr 28, 2015

Keywords

ClinConnect Summary

This study is a multi-centre randomized controlled, open label, phase II trial for patients with de-novo GBM.

Eligible patients will be randomized between arm A and arm B:

Arm A (standard): Radiotherapy and chemotherapy according to standard protocol for newly diagnosed GBM. This consists of 30 daily fractions of 2 Gy or 33 fractions in 1.8 Gy to the tumor and surrounding margin in combination with temozolomide 75 mg/m² per os daily (po qd) and six adjuvant cycles of temozolomide 150 - 200 mg/m² po qd.

Arm B (experimental): Standard treatment as described under arm A combined with daily ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed grade IV supratentorial astrocytoma, IDH wildtype (glioblastoma multiforme)
• • Tumor tissue available for histopathological analysis
• • Diagnosis must have been made by biopsy or resection lower or equal than 3 months prior to study entry
• • 18 - 70 years
• • Karnofsky performance status greater or equal than 70
• • Absolute neutrophil count at least 1.5 x 109/L and platelets at least 100 x109/L
• • Adequate renal function
• • Adequate hepatic function
• • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• • Females must have negative results for pregnancy tests performed
• • No breast feeding.
• • If male, subject must be surgically sterile or practicing a method of contraception
• • Ability to swallow and take oral medication.
• Exclusion Criteria:
• • Prior radiotherapy
• • Prior chemotherapy
• • Pregnancy or breast feeding
• • Recent (less than 3 months) severe cardiac disease (NYHA class greater than 1) (congestive heart failure, infarction)
• • History of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment, or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
• • Cardiac conduction disturbances or medication potentially causing them
• • Treatment with investigational drugs in 4 weeks prior to or during this study
• • If the subject has clinically significant and uncontrolled major medical condition(s)
• • Psychiatric illness/social situation that would limit compliance with study requirements
• • Any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
• • The subject has had another active malignancy within the past 3 years except for any cancer in situ that the principal Investigator considers to be cured.
• • Chronic systemic immune therapy (with the exception of corticosteroids)
• • Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
• • Known glucose-6-phosphate dehydrogenase deficiency
• • Psoriasis or porphyria
• • Known hypersensitivity to 4-aminoquinoline compound
• • Retinal or visual field changes unrelated to the tumor location prior to 4-aminoquinoline compound use