Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.

• NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension (Drug), also known as docetaxel: NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.

Primary outcomes

• Number of participants with treatment emergent adverse events [Day 1 to 180 days post-last NanoDoce injection]: Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Secondary outcomes

• Concentration of docetaxel in the systemic circulation post-injection [Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection]: Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Signed informed consent;
* Age ≥18 years;
* Localized T1a renal cell carcinoma;
* Maximum tumor volume of 25.0 mL;
* Performance Status (ECOG) 0-2;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function;

  * ANC ≥ 1.5 x 109/L
  * Hemoglobin ≥ 9.5 grams/dL
  * Platelets ≥ 75 x 109/L
  * Total bilirubin ≤ 1.5x institutional ULN
  * AST/ ALT ≤ 2.5x institutional ULN
  * Creatinine ≤ 1.5x institutional ULN
  * eGFR < 60 mL/min/1.73m2
* Adequate method of birth control.

Exclusion Criteria:

* Renal cyst;
* Multifocal or bilateral renal mass;
* Known hypersensitivity to any of the study drug or reconstitution components;
* Pregnant or breastfeeding female;
* Administration of an investigational product in a clinical trial within 3 months prior to consent;
* Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
* Known drug or alcohol abuse.

• Rose Marie Cavanna-Mast, RT, CCRA, Study director, US Biotest, Inc.