Temozolomide in Elderly Patients With KPS < 70

NCT01242566 | Completed Phase 2

• 1 other identifier: P060102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Brain Tumor; Glioblastoma

Keywords

Temozolomide; Elderly; Glioblastoma; Karnofsky performance score (KPS)

Outcome Measures

Primary Outcomes (1)

• Overall survival

  12 months

Secondary Outcomes (5)

• Progression-free survival

  12 months

• adverse events

  12 months

• Health-related quality of life

  12 months

• Cognitive functioning

  12 months

• Efficacy according to MGMT Promoter methylation status

  12 months

Study Arms (1)

temozolomide

EXPERIMENTAL

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

Interventions

Temozolomide DRUG

orally 150-200 mg/m2/day for 5 consecutive days every 4 week

Also known as: Temodar, Temodal

temozolomide

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association de Neuro-Oncologues d'Expression Francaise: collaborator

Study Sites (1)

Pitie salpetriere hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; 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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• DELATTRE Jean-Yves, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: July 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 17, 2010

Record last verified: 2009-11

Locations

FR (1)