Clinical trial · Interventional
Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma
A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
NCT00703859CI-TRIAL-00021017withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dichloroacetate (DCA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.