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Compares treatment options for Glioblastoma Multiforme
Official title Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
ClinicalTrials.gov ID: NCT04765098
What this study is testing
What is Tamoxifen?
Tamoxifen is an investigational medicine, given as an once-daily, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- ECOG performance 0-2 (Appendix 2).
You likely can't join if
- History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a...
- 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.
- Substantial cardiovascular disease: cerebral vascular accident/stroke (\ New York Heart Association Classification Class II), or serious cardiac...
See the full eligibility criteria
- 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.
- ECOG performance 0-2 (Appendix 2).
- Age from 18-65 years.
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and...
- Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study...
- Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
- ANC ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Serum creatinine ≤ 1.5 times ULN
- Total serum bilirubin ≤ 1.5 times ULN
- ALT \< 3 times ULN
- AST \< 3 times ULN
- Alkaline phosphatase \< 3 times ULN
- Patient must understand and sign an informed consent prior to study registration.
- 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...
- 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.
- Substantial cardiovascular disease: cerebral vascular accident/stroke (\ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.