Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

NanOlogy

Status and phase: Withdrawn; Phase 1

Conditions: Adenocarcinoma, Renal; Kidney Cancer; Adenocarcinoma of Kidney; Renal Cell Cancer; Renal Cell Carcinoma

Treatments: Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT04260360

NANODOCE-2018-01

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

NanoDoce

Experimental group

Description:

Intratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses.

Treatment:

Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension