Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks

Cabazitaxel

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.

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 -

* Rates of deaths within 12 weeks
* Hematological and non hematological toxicity grade ≥ 2 according to CTCAE V4.0

Pharmacokinetics of cabazitaxel in patients with and without concomitant anticonvulsive medication with respect to induction of CYP3A

Assessment of quality of life, determined by assessment with EORTC QLQ questionnaires (C30 and BN20), and neurocognitive functioning, determined by repeated standardized measurements using MMSE

University of Ulm

Prof. Dr. med.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme	NCT01866449	Glioblastoma Mu...	Cabazitaxel	18 Years -	University of Ulm
Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme	NCT01866449	Glioblastoma Mu...	Cabazitaxel	18 Years -	University of Ulm

Spots Global Cancer Trial Database for glioblastoma multiforme (gbm) who grade iv