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

NCT01866449 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-26

No results posted yet for this study

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

DRUG

Cabazitaxel

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-12-31
Completion
2017-08-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01866449 on ClinicalTrials.gov