NCT01866449

Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme

Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme (GBM) WHO Grade IV

Interventions

Type	Name	Description
DRUG	Cabazitaxel

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-12-01
• Completion: 2017-08-25
• First posted: 2013-05-31
• Last updated: 2017-10-26

Locations

3 sites across 1 country: Germany