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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00703859
First received: June 23, 2008
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Glioblastoma
 Drug: Dichloroacetate (DCA)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703859

Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Bassam Abdulkarim, MD, FRCPC Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00703859     History of Changes
Other Study ID Numbers: CNS-24139
Study First Received: June 23, 2008
Last Updated: September 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Radiotherapy plus temozolomide plus DCA
PK profile of DCA
MGMT promoter methylation status
Newly diagnosed Glioblastoma multiform tumours

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013