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Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma

Study Purpose

This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus Dichloroacetate (DCA) improves overall survival and offers better control of the disease in patients with newly diagnosed Glioblastoma Multiforme Tumours.

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:

  • - newly diagnosed GBM.
  • - Diagnosis must be established by open biopsy or tumour resection.
  • - Tumour must have a supratentorial component.
  • - Over 18 years.
  • - pre-treatment evaluations must be met.
  • - study therapy to begin within 6 weeks of surgery.
  • - KPS greater or equal to 70.
  • - patients must sign informed consent.
  • - If female, patients must not be pregnant or lactating.
  • - Women of childbearing potential and male participants must practice adequate contraception.

Exclusion Criteria:

  • - prior invasive malignancy )except for non-melanomatous skin cancer) unless disease free for greater than 3 years.
  • - recurrent or multifocal malignant gliomas.
  • - metastatic disease of leptomeningeal spread.
  • - prior chemo or radiosensitizers for cancers of the head and neck region.
  • - prior RT to head and neck region except for T1 glottic cancer, resulting in overlap of radiation fields.
  • - Severe active co-morbidity define in protocol.
  • - Pregnant of lactating women.
  • - Women of childbearing potential or men who are sexually active who are not willing or able to use medically acceptable forms of contraception; this exclusion is necessary due to the treatment involved potentially being teratogenic.
  • - prior allergic reaction to temozolomide and/or dichloroacetate.
- History of HIV/AIDS

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.

 NCT00703859
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 1
Lead Sponsor

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

 AHS Cancer Control Alberta
Principal Investigator

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

 Bassam Abdulkarim, MD, FRCPC
Principal Investigator Affiliation AHS Cancer Control Alberta
Agency Class

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

 Other
Overall Status Withdrawn
Countries
Conditions

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

 Glioblastoma
Additional Details

Patients with newly diagnosed Glioblastoma Multiforme Tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (TMZ) with DCA in pill form (twice a day) during the radiation phase of the study and then with TMZ for six months after. Other elements of the clinical trial include pharmacokinetics and MGMT genetic testing.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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