Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme - Full Text View

Purpose

The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: Zarnestra Procedure: standard Radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:

Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy [ Time Frame: time of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate (RECIST and volumetric criteria) [ Time Frame: time of study ] [ Designated as safety issue: No ]
Median survival, 6 month and 1 year survival rates [ Time Frame: 6 month and 1 year ] [ Designated as safety issue: No ]
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters [ Time Frame: time of study ] [ Designated as safety issue: Yes ]

Enrollment:	27
Study Start Date:	October 2005
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.

Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have pathologically confirmed (histology or cytology), resectable or non resectable, glioblastoma multiforme with a size < 5 cm on MRI if non resectable
Patients must be at least 7 days but no more than 2 months since surgery or biopsy.
Patients must have an ECOG Performance Status ≤ 2.
Patients must be aged 18
Patient has signed the informed consent form

Exclusion Criteria:

Patients with unresectable glioblastoma with a size >5 cm on MRI
Patients with clinically apparent leptomeningeal metastases
Patients with uncontrolled seizures despite standard anticonvulsant therapy
Any prior systemic treatment (chemotherapy, immunotherapy, hormonal therapy) for glioblastoma multiforme
Significantly abnormal haematological status as judged by:

Absolute neutrophil count (ANC) < 1500/mm3 (1.5*109/l) Platelet count <100,000/mm3 (100*109/l)

Serum bilirubin >2 mg/dl (>34 mmol/l) or Transaminase >2.5x the upper limit of institutional normal or Creatinine >1.5 mg/dl (>132 mmol/l)
Inability to co-operate with the treatment protocol
Patients who cannot undergo imaging evaluations
Participation in an investigational drug trial in the 30 days prior to selection
Pregnant or nursing mothers. (Female patients of childbearing potential must use adequate contraception.)
Any malignancy within the past five years. Exceptions are: superficial basal cell carcinoma or non-metastatic squamous cell cancer of the skin, cervix cancer (cervical intra-epithelial neoplasia -CIN or FIGO stage 1) or prostate intra-epithelial neoplasia (PIN), biochemical relapse free for at least 3 years.
Any prior systemic chemotherapy in the past five years for any malignancy in the medical history
Any concurrent disease that in the opinion of the investigator would constitute a hazard for participating in this study
Known sensitivity to imidazole derivatives
Patients under law protection
Medical history of phlebitis or pulmonary embolism, thrombocytosis, myocardiopathy, or other relevant cardiac pathology (auricular flutter, auricular fibrillation)
Medical history of immuno-allergic pneumopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209989

Locations

France
Centre Jean Perrin
Clermont Ferrand, France
Institut Claudius Regaud
Toulouse, France

Sponsors and Collaborators

Institut Claudius Regaud

Janssen-Cilag Ltd.

Investigators

Principal Investigator:

Elizabeth MOYAL, Dr

Institut Claudius Regaud

More Information

No publications provided

Responsible Party:	Institut Claudius Regaud
ClinicalTrials.gov Identifier:	NCT00209989 History of Changes
Other Study ID Numbers:	02 TETE 02
Study First Received:	September 13, 2005
Last Updated:	November 23, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:

Glioblastoma Multiforme
Zarnestra
Radiation therapy

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Tipifarnib
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013