Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

• Status: Withdrawn
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Docetaxel

Criteria

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.