Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects with Urothelial Carcinoma
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary purpose of this study is to see if NanoDoce is safe, effective, and reliable in killing bladder cancer cells in patients with high risk non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC).NanoDoce will be given in two different ways: 1) as an injection in the bladder wall after a TURBT, and 2) as a fluid inserted in the bladder by catheter (intravesical instillation) right after the injection. This study is the first time that NanoDoce is given to people, meaning that the effects and correct dose are not yet known.NanoDoce is an investigational version of the chemotherapy drug docetaxel (the "Doce"), where the drug exists as very small particles/fine powder (the "Nano"). Other goals for this study include measuring how much docetaxel enters the systemic circulation after the injection, as well as evaluating how long the patient remains tumor-free after the treatment.
Patients must have a confirmed diagnosis of high risk NMIBC or MIBC. High risk NMIBC is defined as: high grade (HG) T1; any recurrent TG Ta; greater than 3 cm or multifocal HG Ta; any carcinoma in situ (CIS); any BCG failure for HG cancer; any variant histology; and/or any lymphovascular invasion (LVI), including any HG prostatic urethral involvement. Patients must have urothelial carcinoma confirmed by biopsy, cytology, CT scan, or another JHMI-approved diagnostic method. Patients must have all visible tumors removed during a TURBT. Patients must be able to perform all of their own self-care activities without assistance. Patients must have a life expectancy of at least 6 months. Patients must have adequate bone marrow, liver, and renal function, as determined by routine laboratory tests. Patients must use an adequate method of birth control.Patients must NOT have metastatic disease. Patients must NOT have previous (within the past 12 months) or ongoing history of any non-bladder malignancy, except for non-melanoma skin cancer. Patients must NOT have had any intravesical therapy (chemotherapy or immunotherapy, including BCG administered directly into the bladder) within the past 6 weeks. Patients must NOT have had upper tract and/or urethral disease within the past 18 months. Patients must NOT have any known hypersensitivity or allergy to any of the study drug components or reconstitution components. Patients must NOT be pregnant or breastfeeding. Patients must NOT have participated in the treatment phase of another clinical trial within the past 3 months. Patients must NOT have any ongoing drug or alcohol abuse. Patients must NOT have any disorders that would prevent them from complying with the protocol.
Eligible patients will be placed into one of two groups: 1) NMIBC, and 2) MIBC. Group 1 patients will receive NanoDoce injection into the part of the bladder where the tumor was removed and then NanoDoce instillation into the entire bladder. Group 1 patients will then be treated with NanoDoce instillations weekly for a total of six (6) weeks. If it is determined that the patient is still cancer-free, about six (6) weeks after the last instillation, Group 1 patients will receive maintenance NanoDoce instillations weekly for three (3) additional weeks. Group 2 patients will receive NanoDoce injection into the part of the bladder where the tumor was removed and then NanoDoce instillation into the entire bladder. Group 2 patients will not receive the weekly NanoDoce instillations.
02/17/2020 05:03 AM