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

AHS Cancer Control Alberta

Status and phase

Withdrawn

Phase 1

Conditions

Glioblastoma

Treatments

Drug: Dichloroacetate (DCA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00703859

CNS-24139

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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