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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00703859
• Date of registration: 23/06/2008
• Primary sponsor: Alberta Health Services
• Public title: Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma
• Scientific title: A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
• Date of first enrolment: July 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00703859
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Bassam Abdulkarim, MD, FRCPC
• Affiliation: Alberta Health Services

Key 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glioblastoma

Intervention(s)

Drug: Dichloroacetate (DCA)

Primary Outcome(s)

Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients. [Time Frame: 2 years]

Secondary Outcome(s)

To determine if there is a correlation between MGMT promoter methylation status and progression-free survival for newly diagnosed GBM patients undergoing concurrent TMZ, DCA and RT followed by six monthly cycles of TMZ and DCA [Time Frame: 2 years]

Secondary ID(s)

CNS-24139

Source(s) of Monetary Support

Please refer to primary and secondary sponsors