Back to results

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

Primary Purpose

Glioblastoma

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Dichloroacetate (DCA)

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Radiotherapy plus temozolomide plus DCA, PK profile of DCA, MGMT promoter methylation status, Newly diagnosed Glioblastoma multiform tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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.

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

Full Information

NCT ID

NCT00703859

First Posted

June 23, 2008

Last Updated

February 18, 2016

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT00703859

Brief Title

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

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Withdrawn

Study Start Date

July 2008 (undefined)

Primary Completion Date

January 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dichloroacetate (DCA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bassam Abdulkarim, MD, FRCPC

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs