Clinical trial NCT01989884: An Efficacy Study Of Ortataxel In Recurrent Glioblastoma
Official title: Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Detailed description: In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed GBM.
* GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
* Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
* No more than one prior line of chemotherapy (Temozolomide).
* Recovery from the toxic effects of prior therapy.
* Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:

  1. Surgery must have confirmed the recurrence.
  2. A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
  3. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration.
* Age ≥ 18 years.
* Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
* Karnofsky-PS ≥ 60%.
* Stable or decreasing dose of corticosteroids within 5 days prior to registration.

Exclusion Criteria:

* Patients unable to undergo brain MRI scans with gadolinium (iv).
* Pre-existing peripheral neuropathy, grade ≥ 2.
* History of intracranial abscess within 6 months prior to registration.
* Anticipation of need for major surgical procedure during the course of the trial.
* Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period

Primary outcomes:
measure: progression free survival-6
timeFrame: after 6 months after randomization
Secondary outcomes:
measure: progression free survival
timeFrame: after 9 months of follow-up for each patient
measure: Overall survival-9
timeFrame: 9 months after randomization
measure: Objective response rate
timeFrame: after 9 months of follow-up for each patient
measure: Number of patients with AEs, SAEs, SADRs, SUSARs
timeFrame: after 9 months of follow-up for each patient
measure: treatment compliance
timeFrame: 9 months after randomization
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Ospedale di Lecco
city: Milano
country: Italy
facility: A.O. OSpedale Niguarda Ca' Granda
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Carlo Besta Neurological Foundation
city: Pavia
country: Italy
facility: Fondazione "Salvatore Maugeri"
city: Pavia
country: Italy
facility: IRCCS Fondazione "Casimiro Mondino"
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
name: Antonio Silvani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silvani A, De Simone I, Fregoni V, Biagioli E, Marchioni E, Caroli M, Salmaggi A, Pace A, Torri V, Gaviani P, Quaquarini E, Simonetti G, Rulli E, D'Incalci M; Italian Association of Neuro-Oncology. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma. J Neurooncol. 2019 May;142(3):455-462. doi: 10.1007/s11060-019-03116-z. Epub 2019 Feb 6.