Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with 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.

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.