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A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Glioblastoma

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Trial Information

A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Bassam Abdulkarim, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

CNS-24139

NCT ID:

NCT00703859

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Glioblastoma
  • Radiotherapy plus temozolomide plus DCA
  • PK profile of DCA
  • MGMT promoter methylation status
  • Newly diagnosed Glioblastoma multiform tumours
  • Glioblastoma

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