Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

NCT00575887 | Completed Phase 2 Results DMC

• 1 other identifier: MU-RO-2005-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Tumor, Recurrent

Keywords

Temozolomide; Brain Tumor, Recurrent; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival at 6-months

  Until progression

Study Arms (1)

1

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity

Also known as: Temodal, Temodar

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age \>18 years old
• Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
• Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
• Karnofsky Performance Status scale \>/=50 (due to brain pathology)
• Adequate hematological, renal and hepatic function
• Patients willing to participate in the study and signing the informed consent

You may not qualify if:

• Karnofsky Performance Status scale \<50
• Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
• Patients not suitable for follow-up

Sponsors & Collaborators

• Marmara University: lead
• Schering-Plough: collaborator

Study Sites (1)

Marmara University Hospital

Istanbul, 34660, Turkey (Türkiye)

Location

Related Publications (1)

• Abacioglu U, Caglar HB, Yumuk PF, Akgun Z, Atasoy BM, Sengoz M. Efficacy of protracted dose-dense temozolomide in patients with recurrent high-grade glioma. J Neurooncol. 2011 Jul;103(3):585-93. doi: 10.1007/s11060-010-0423-2. Epub 2010 Sep 29.

  PMID: 20878446 RESULT

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ufuk Abacioglu
• Organization: Marmara University

ufuk@abacioglu.com

902123853100

Study Officials

• Ufuk ABACIOGLU, MD

  Marmara University Hospital, Radiation Oncology Department

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 18, 2007
• Study Start: August 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 20, 2013
• Results First Posted: December 20, 2013

Record last verified: 2013-11

Locations

TU (1)