Status:
TERMINATED
Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Inflammatory Breast Cancer Network Foundation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Baseline Fluid Collection: Before receiving the study drug or the placebo, pleural fluid will be drained from your catheter to be compared to fluid collected later in the study. Study Groups: You w...
Eligibility Criteria
Inclusion
- 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
- 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.
- Known urea cycle disorders based on history.
- Known HIV infection based on history.
- Active or recent pancreatitis (within last 6 months).
- Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks and incompletely healed surgical incision before randomization.
- Evidence of empyema or history of empyema of the affected hemithorax.
- Non-correctable bleeding diathesis.
- Clinical evidence of skin infection at the potential site of IPC placement.
- Patients currently taking valproic acid.
- History of hepatitis or liver disease.
- The following drugs will not be administered concurrently with VPA: Carbapenem antibiotics; Clonazepam; Topiramate; Felbamate; Lorazepam; Barbiturates; Barbiturates; CarBAMazepine; ChlorproMAZINE; Ethosuximide; GuanFACINE; LamoTRIgine; MethylfolateOXcarbazepine; Paliperidone; Phenytoin; Primidone; Protease Inhibitors; Rifampin; Risperidone; Rufinamide; Salicylates; Temozolomide; Tricyclic Antidepressants; Vorinostat; Zidovudine.
- History of seizures.
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01900730
Start Date
July 31 2014
End Date
June 1 2018
Last Update
February 25 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030