Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomarecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

Treatment success (complete or partial response or a progression-free survival at 6 months)

Secondary Outcomes (5)

Objective response
Duration of response
Toxicity
Progression-free survival at 6 months
Overall survival at 6 and 12 months

Interventions

sagopiloneDrug

fluorescence in situ hybridizationGenetic

gene expression analysisGenetic

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma * Presence of oligodendroglial elements allowed provided they make up \< 25% of tumor * Measurable disease, defined as ≥ 1 bidimensionally measurable target lesion with a largest diameter of ≥ 2 cm by MRI within the past 2 weeks * Recurrent disease * Documented by MRI after failing prior therapy (usually standard radiotherapy with concurrent and maintenance temozolomide) * Subsequent histologic confirmation of recurrence required for patients who received prior high-dose radiotherapy (\> 65 Gy), stereotactic radiosurgery, or internal radiotherapy * Multifocal disease that is not amenable to radiotherapy allowed provided the patient received no more than 1 line of prior chemotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST and ALT \< 2.5 times ULN * Alkaline phosphatase \< 2.5 times ULN * Creatinine \< 1.5 times ULN * Clinically normal cardiac function * No ischemic heart disease within the past 12 months * Stable ischemic heart disease (e.g., treated angina that is stable under appropriate therapy) allowed * No New York Heart Association class III or IV cardiac insufficiency * No unstable angina * No arrhythmia * No psychological, familial, sociological, or geographical factors that would preclude study compliance * No other malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use effective contraception during and for 3 months after completion of study treatment * Fertile male patients must use effective contraception during and for 6 months after completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * More than 3 months since prior radiotherapy to the brain * More than 3 months since prior surgery for recurrent primary brain tumor unless 1 of the following criteria are met: * Measurable residual disease documented by immediate (within 72 hours) postoperative imaging * Evidence of a progressive and measurable target lesion found at postoperative follow-up * Presence of a second measurable target lesion outside the surgical area * Prior adjuvant temozolomide as first-line therapy allowed * No prior chemotherapy for recurrent glioblastoma * One prior chemotherapy regimen given as adjuvant therapy allowed * Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week * No concurrent phenytoin, carbamazepine, or phenobarbital * No concurrent Hypericum perforatum (St. John's wort) * No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) * Patients on EIAEDs should have been switched to non-EIAEDs with a wash-out period of ≥ 1 month * No other concurrent anticancer agents (except alternative or homeopathic medicine) * No other concurrent investigational treatment

Sponsors & Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
Research networklead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Related Publications (2)

Stupp R, Tosoni A, Bromberg JEC, Hau P, Campone M, Gijtenbeek J, Frenay M, Breimer L, Wiesinger H, Allgeier A, van den Bent MJ, Bogdahn U, van der Graaf W, Yun HJ, Gorlia T, Lacombe D, Brandes AA. Sagopilone (ZK-EPO, ZK 219477) for recurrent glioblastoma. A phase II multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) Brain Tumor Group. Ann Oncol. 2011 Sep;22(9):2144-2149. doi: 10.1093/annonc/mdq729. Epub 2011 Feb 14.
PMID: 21321091RESULT
Stupp R, Tosoni W, Taal W, et al.: Phase II trial of the epothilone analog sagopilone (ZK219477; ZK EPO) in patients with recurrent glioblastoma: initial report of the EORTC study 26061. [Abstract] J Clin Oncol 26 (Suppl 15): A-2015, 2008.
RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaBrain NeoplasmsGliosarcoma

Interventions

sagopiloneIn Situ Hybridization, FluorescenceGene Expression ProfilingImmunohistochemistry

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGlioma

Study Officials

Roger Stupp, MD
Centre Hospitalier Universitaire Vaudois
STUDY CHAIR

Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations