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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00703859
• Other study ID #: CNS-24139
• Status: Withdrawn
• Phase: Phase 1
• First received: June 23, 2008
• Last updated: February 18, 2016
• Start date: July 2008

Study information

• Verified date: September 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients.		2 years	No
Secondary	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		2 years	No