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

NCT00703859 | Withdrawn Phase 1 DMC

• 1 other identifier: CNS-24139
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Keywords

Radiotherapy plus temozolomide plus DCA; PK profile of DCA; MGMT promoter methylation status; Newly diagnosed Glioblastoma multiform tumours

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

Dichloroacetate (DCA) DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• prior allergic reaction to temozolomide and/or dichloroacetate
• History of HIV/AIDS

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Bassam Abdulkarim, MD, FRCPC

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: February 22, 2016

Record last verified: 2011-09