Phase
Condition
Gliomas
Astrocytoma
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient must be 18-80 years old
- Patients must have histologically confirmed WHO grade IV glioma that is progressive orrecurrent following at least one prior TMZ plus radiation therapy regimen
- Patients must have recurrent GBM as determined by neuroimaging and some degree ofsymptomatology (e.g., headache, mental status change, seizure), and have clinicallyindicated tumor debulking surgery planned
- Patients must have recovered (
- 12 weeks from the completion of radiation.
- 6 weeks from a nitrosourea chemotherapy
- 3 weeks from a non-nitrosourea chemotherapy
- 4 weeks from any investigational (not FDA-approved) agents
- 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g.,erlotinib, hydroxychloroquine, etc.)
- Must have completed Standard of Care RT and TMZ. Patients must have received at least 80% of planned TMZ/RT treatment?
- Patients must have a Karnofsky Performance (KPS) Status >/= 60% (i.e. the patient mustbe able to care for himself/herself with occasional help from others).
- Patients may retain whatever medications they are receiving for other conditions (e.g., hypertension, seizures), except patients requiring insulin or sulfonylureatherapy, these patients will not be eligible.
- Women of childbearing potential must have a negative serum pregnancy test within 7days of dosing. Women of childbearing potential and men must agree to use highlyeffective contraception prior to study entry, for the duration of study participation,and for at 30 days after the last dose of study drug.
- Patients must have the following organ and marrow function:
(1) Absolute neutrophil count >1,500/ µL (2) Platelets ≥100,000/ µL (3) Hemoglobin ≥ 9 g/dL (4) Total bilirubin ≤ 2mg/dl (5) AST (SGOT)/ALT (SGPT) ≤3 × institutional upper limit ofnormal (6) GFR > 30ml/min 10. Patients must be able to undergo MRI of the brain with gadolinium. Patients must bemaintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5days) prior to this baseline MRI. 12. Patients must be able to provide written informed consent. 13. Patients must have no concurrent malignancy except curatively treated basal or squamouscell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patientswith prior malignancies must be disease-free for >/= 3 years. 14. Patients must be able to swallow liquid
Exclusion
Exclusion Criteria:
- Patients receiving any other investigational agents for brain tumor are ineligible.
- Patients who have not recovered to
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoingor active infection, symptomatic congestive heart failure, clinically significantcardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatricillness/social situations that would limit compliance with study requirements, areineligible.
- Pregnant women are excluded from this study because the effects of DCA on a fetus areunknown. Because there is an unknown but potential risk for adverse events in nursinginfants secondary to treatment of the mother with DCA, breastfeeding should bediscontinued if the mother is treated with DCA.
- Patients who require insulin or sulfonylurea therapy.
Study Design
Study Description
Connect with a study center
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available


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