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Epothilone in Recurrent Glioblastoma Patients

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ClinicalTrials.gov Identifier: NCT00397072
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Antonio Silvani, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study Description
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Brief Summary:
The purpose of this single arm phase II study is to evaluate safety and efficacy of ZK 219477 in the treatment of temozolomide pre-treated, recurrent GBM patients.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: ZK 219477 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study: Systemic Treatment With iv ZK219477-Epothilone in Recurrent Glioblastoma Patients
Study Start Date : June 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ZK-EPO
administered iv for 3 h every 21 days; dose reductions to 12 or 9 mg/m2 ZK-EPO were allowed in order to manage any treatment-related toxicity.
 Drug: ZK 219477


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival at six months (PFS-6). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Response rates (CR +PR) [ Time Frame: 2 years ]
    Secondary end-points

  2. Safety evaluation according to CTC-AE [ Time Frame: 2 years ]
  3. Median Survival Time (MST) [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years
  • KPS ≥ 70
  • Life expectancy of at least 3 months
  • Presence of at least one bi-dimensionally measurable lesion on gadolinium (Gd)-enhanced MRI, indicating progressive or recurrent disease at least 8 weeks after standard external-beam radiotherapy
  • Recurrence or progression after treatment with radiotherapy and temozolomide. Also patients with residual disease after surgery for recurrent GBM will be included
  • Adequate bone marrow reserve (leukocytes ≥ 3,500/ml, ANC ≥ 1,500/ml, platelets ≥100,000/ ml); normal baseline liver (serum bilirubin ≤ 20 /mol/ L), renal (serum creatinine <150 /mol/L) and cardiac function
  • Absence of infectious disease, debilitating chronic diseases, and known psychiatric disorders
  • Corticosteroid dose stable for at least 1 week
  • Adequate recovery from previous surgery, radiation and chemotherapy
  • Negative pregnancy test at enrolment in females of child-bearing potential
  • Agreement to use highly effective contraception methods in adults of reproductive potential
  • Fully informed written consent

Exclusion Criteria:

  • Pregnant women
  • Patients who have had chemotherapy or radiotherapy within 4 weeks
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZK219477
  • Uncontrolled inter current illness including, but not limited, to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • HIV-infection
  • Any prior treatment with epothilones, other tubulin-targetting as taxanes (e.g. paclitaxel, docetaxel) and vinca alkaloids (e.g. vincristine, vinblastine, vinorelbine)
  • Peripheral neuropathy
  • Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
  • Active infection
  • Breast-feeding
  • Subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
  • Employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre
Contacts and Locations
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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): NCT00397072


Locations
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Italy
Istituto Nazionale Neurologico
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Investigators
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Principal Investigator: Amerigo Boairdi, MD Istituto Nazionale Neurologico Carlo Besta
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Antonio Silvani, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT00397072     History of Changes
Other Study ID Numbers: ZK219477IV
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by Antonio Silvani, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:
Glioblastoma recurrent,temozolomide, epothilone
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Epothilones
Sagopilone
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents