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Temozolomide in Elderly Patients With KPS < 70 (TAG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242566
First Posted: November 17, 2010
Last Update Posted: November 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Association de Neuro-Oncologues d’Expression Francaise
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

Condition Intervention Phase
Primary Brain Tumor Glioblastoma Drug: Temozolomide Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ]
  • adverse events [ Time Frame: 12 months ]
    term, grade, frequency

  • Health-related quality of life [ Time Frame: 12 months ]
    KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)

  • Cognitive functioning [ Time Frame: 12 months ]
    characterized by MMSE

  • Efficacy according to MGMT Promoter methylation status [ Time Frame: 12 months ]

Enrollment: 70
Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: temozolomide
Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity
Drug: Temozolomide
orally 150-200 mg/m2/day for 5 consecutive days every 4 week
Other Name: Temodar, Temodal

Detailed Description:

This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status.

Patients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.

Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.

Patients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed supratentorial glioblastoma
  • Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
  • Patients aged 70 years or older
  • KPS above 30 and below 70
  • Life expectancy higher than 4 weeks
  • Clinical examination at baseline
  • Affiliation to Social Security or mandatory beneficiary
  • Patient being informed and obtention of written informed consent

Exclusion Criteria:

  • Prior surgical resection dated more than 1 month before inclusion
  • Prior brain radiotherapy or chemotherapy
  • Severe underlying disease which could interfere with survival
  • History of hypersensibility reaction on temozolomide components
  • Severe bone marrow hypoplasia
  • Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
  • Absolute neutrophil count < 1.5x109 cells per liter
  • Platelet count < 100x109 cells per liter
  • Hemoglobin < 9 g/dl
  • Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01242566


Locations
France
Pitie salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association de Neuro-Oncologues d’Expression Francaise
Investigators
Principal Investigator: DELATTRE Jean-Yves, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Isabelle Brindel, Department Clinical Research
ClinicalTrials.gov Identifier: NCT01242566     History of Changes
Other Study ID Numbers: P060102
First Submitted: November 16, 2010
First Posted: November 17, 2010
Last Update Posted: November 17, 2010
Last Verified: November 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Temozolomide
Elderly
Glioblastoma
Karnofsky performance score (KPS)

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents