Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT01866449|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme (GBM) WHO Grade IV||Drug: Cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||August 25, 2017|
Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks
Other Name: Jevtane
- Response including SD, PR or CR determined by MRI (modified RANO criteria) [ Time Frame: 1 year ]• Response after 12 weeks
- Overall and progression-free survival [ Time Frame: 3 years ]
- Safety and tolerability [ Time Frame: 3 years ]
- Rates of deaths within 12 weeks
- Hematological and non hematological toxicity grade ≥ 2 according to CTCAE V4.0
- Pharmacokinetics data concerning drug interactions (i.e. CYP3A induction) [ Time Frame: 3 years ]Pharmacokinetics of cabazitaxel in patients with and without concomitant anticonvulsive medication with respect to induction of CYP3A
- Quality of life and neurocognitive functioning [ Time Frame: 3 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866449
|Hämatologisch onkologische Praxis|
|Augsburg, Germany, 86150|
|Stiftungsklinikum Mittelrhein GmbH|
|Koblenz, Germany, 56068|
|Lars Bullinger, MD|
|Ulm, Germany, 89081|