Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
ConditionGlioblastoma Multiforme
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAHS Cancer Control Alberta
About this trial
The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.
Eligibility criteria
Qualifiers
Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.
Not received radiotherapy within the three months before the diagnosis of progression.
Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.
Disqualifiers
History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg).
Any arterial or venous thrombosis up to 6 months before registration.
Evidence of recent hemorrhage on brain MRI.
Trial design
Treatments tested in this trial
- Tamoxifen
- Etoposide
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov