A Phase II Open-labeled, Double-arm Clinical Study of Dichloroacetate (DCA) in Malignant Gliomas and Glioblastome Multiforme (GBM) Patients
- Patients must have histologically confirmed intracranial malignant glioma / GBM
- All patients enrolled must have measurable with or without evaluable disease, as
defined in Section 11.
- In the recurrent malignant glioma cohort of patients, four weeks must have elapsed
from prior chemotherapy or radiation therapy.
- Age 18 years and over.
- ECOG (Eastern Cooperative Oncology Group) performance status Grade 0-2 (Karnofsky
- Life expectancy of greater than 12 weeks.
- Patients must have liver, kidney and marrow function as defined below:
- absolute neutrophil count >1,500/mcL
- hemoglobin >90 g/L
- platelets >100,000/mcL
- total bilirubin <1.5 X upper limit of normal (ULN)
- AST(SGOT) and ALT(SGPT) <1.5 X ULN
- creatinine <1.5 X ULN
- Recovery to baseline or, at most, grade 1 of all drug-related toxicities due to prior
chemotherapy, radiation, or molecular targeted therapy, except for alopecia.
- Women of child-bearing potential and men must agree to use adequate contraception
(e.g.: hormonal or barrier method of birth control, abstinence) prior to study entry
and for the duration of study participation. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately.
- Patients must be able to understand and be willing to sign a written informed consent
- Patients who have had chemotherapy, molecular targeted therapy, or radiotherapy
within 4 weeks prior to entering the study or those who have not recovered from
adverse events due to agents administered more than 4 weeks earlier.
- Patients with new onset or increasing dose regimen of steroids for the week prior to
- Patients cannot be receiving any other investigational therapies.
- Patients with grade 2 or higher peripheral neuropathy due to prior medical condition
(such as multiple sclerosis, diabetes etc), medications (chemotherapy), or other
- Greater than 0.8 cm brain midline shift on CT scan or MRI
- Any psychological, familial, sociological, or geographical conditions that do not
permit medical follow-up and compliance with the study protocol.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled diabetes with history of significant hypoglycemic episodes
in the past 3 months or psychiatric illness/social situations that would limit
compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with DCA. In addition, these patients
are at increased risk of lethal (and at time intracranial) infections when treated
with potentially marrow-suppressive therapy.
- History of malabsorption syndrome or substantial amount of small bowels or stomach
resection or obstruction that may impair absorption of DCA.