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

NCT ID: NCT00703859

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dichloroacetate (DCA)

DCA starting at an initial dose of 3mg/kg twice daily PO for consecutive days (days 1-5) on a 28 days cycle up to 6 cycles unless evidence of tumour progression. Each dose to be administered with food at the same time everyday 12 hours apart.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bassam Abdulkarim, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

AHS Cancer Control Alberta

Other Identifiers

CNS-24139

Identifier Type: -

Identifier Source: org_study_id