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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00575887
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Marmara University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ufuk ABACIOGLU, MD
Principal Investigator Affiliation Marmara University Hospital, Radiation Oncology Department
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Completed
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Tumor, Recurrent
Arms & Interventions

Arms

Experimental: 1

Interventions

Drug: - Temozolomide

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Marmara University Hospital, Istanbul, Turkey

Status

Address

Marmara University Hospital

Istanbul, , 34660