Clinical trial NCT00703859: Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma
Official title: A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Radiotherapy plus temozolomide plus DCA
PK profile of DCA
MGMT promoter methylation status
Newly diagnosed Glioblastoma multiform tumours
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients.
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: AHS Cancer Control Alberta
name: Bassam Abdulkarim, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: