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

February 18, 2016 updated by: AHS Cancer Control Alberta

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

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.

Study Overview

Status

Withdrawn

Conditions

Glioblastoma

Intervention / Treatment

Drug: Dichloroacetate (DCA)

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.

Study Type

Interventional

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

Principal Investigator: Bassam Abdulkarim, MD, FRCPC, AHS Cancer Control Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria