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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Temozolomide

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