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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00703859
Recruitment Status : Withdrawn
First Posted : June 24, 2008
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Dichloroacetate (DCA) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
Study Start Date : July 2008
Estimated Primary Completion Date : January 2010

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Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703859


Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
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Principal Investigator: Bassam Abdulkarim, MD, FRCPC AHS Cancer Control Alberta
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00703859    
Other Study ID Numbers: CNS-24139
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: September 2011
Keywords provided by AHS Cancer Control Alberta:
Radiotherapy plus temozolomide plus DCA
PK profile of DCA
MGMT promoter methylation status
Newly diagnosed Glioblastoma multiform tumours
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue