Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme
Status:
Completed
Trial end date:
2017-08-25
Target enrollment:
Participant gender:
Summary
The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of
cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after
last temozolomide treatment (Figure 1).
Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard
concomitant medication (as outlined below):
- On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m²,
administered by i.v. route in 1 hour.
- Cycle length for cabazitaxel is 3 weeks (21 days).
- New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3,
platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have
recovered to baseline.
- A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.
- Patients should come off treatment if treatment delay is more than 2 weeks.
At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v.
premedication including:
- An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In case
of i.v. antihistamine other than promethazine is not being available, local practice
should be followed.
- Corticosteroid (dexamethasone 8mg or equivalent)
- H2 antagonist (ranitidine or equivalent).
- Antiemetic prophylaxis is recommended and can be given orally or intravenously if
necessary.
- Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given
on day 4 of each treatment cycle as per ASCO and ESMO guidelines.