Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma

NCT00424060 | Completed Phase 2

• 3 other identifiers: EORTC-26061EUDRACT-2006-001659-37SPRI-EORTC-26061
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult 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

sagopilone DRUG

fluorescence in situ hybridization GENETIC

gene expression analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

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: 21321091 RESULT

• 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 Neoplasms; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

sagopilone; In Situ Hybridization, Fluorescence; Gene Expression Profiling; Immunohistochemistry

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Histocytochemistry; Immunologic Techniques

Study Officials

• Roger Stupp, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2007
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

CH (1)