M.D. Anderson Cancer Center
To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
Primary Objective: To select an optimal dose of ADI-PEG 20 to combine with carboplatin+cabazitaxel Secondary Objectives: To determine the effects of ADI-PEG 20+carboplatin+cabazitaxel on 1. Serum levels of arginine, citrulline and circulating anti-ADI-PEG 20 antibodies 2. Intratumoral levels of arginine by ion chromatography/mass spectrometry 3. Expression of ASS1 by immunohistochemistry 4. Expression of genes involved in arginine metabolism and downstream pathways 5. Immune checkpoint expression and immune-cell populations in the AVPC tumor microenvironment 6. Safety and tolerability 7. O…
Inclusion Criteria: 1. Completion of informed consent prior to any study specific procedures. 2. Patients must agree to tissue collection for correlative studies at the specified timepoints. 3. Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291. 4. Male aged 18 years and above. 5. Histologically or cytologically confirmed prostate carcinoma. 6. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans). 7. Patients must meet at least one of the following AVPC criteria: i. Histologically proven small cell (neuroe…
Given by Injection
Given by IV (vein)
Given by IV (vein)
Arctuva estimate
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