Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter (NCT01900730) | Clinical Trial Compass
TerminatedPhase 2
Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter
Stopped: Due to low accrual
United States3 participantsStarted 2014-07-31
Plain-language summary
The goal of this clinical research study is to learn if receiving valproic acid (VPA) compared to a placebo can reduce the amount of time you will need to have an indwelling pleural catheter compared to the standard of care, which involves using an indwelling pleural catheter alone.
VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer cells to become less malignant and cause less pleural fluid production.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with symptomatic pleural effusion requiring the presence of an IPC or new placement of an IPC.
✓. Pathologic documentation of breast cancer.
✓. Performance status 0 to 3 (ECOG scale).
✓. Signed informed consent.
✓. Subject must be female or male age 18 years or over.
✓. At least one prior line of chemotherapy in the metastatic setting.
✓. Positive effusion cytology.
Exclusion criteria
✕. Other prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer) from which the patient has been disease-free for at least two years.
✕. Laboratory results sustained at: Neutrophils less than 1.5 × 109/L ; Serum bilirubin \>1.5 x the upper limit of reference range (ULRR); Serum creatinine \>1.5 x ULRR or creatinine clearance \< 30 mL/minute (calculated by Cockcroft-Gault formula).
✕. Patients with a history of existing hypercalcemia, hypocalcemia, hypermagnesemia or hypomagnesemia that is not corrected despite supplementation. Known Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × ULRR or alkaline phosphatase (ALP) \>2 x ULRR, or \> 4x ULRR if judged by the investigator to be related to liver metastases.
✕. Serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, specifically cardiac diseases, uncontrolled hypertension or renal diseases.
✕. Diagnosis of an infection requiring IV antibiotics 14 days prior to registration.
✕. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
✕. Women who are currently pregnant or breast feeding.
✕. Known hypersensitivity to VPA, valproate sodium, disodium valproate, or any ingredient in the respective formulation.