Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2021-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.

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

Details

• Lead Sponsor: Presage Biosciences
• Collaborators: Fred Hutchinson Cancer Research Center; Northwell Health; Oregon Health and Science University; University of Washington
• Treatments: Aldesleukin; Antineoplastic Agents; Atezolizumab; Avelumab; Bortezomib; Docetaxel; Doxorubicin; Durvalumab; Entrectinib; Gemcitabine; Interferon alpha-2; Interferon-alpha; Interferon-gamma; Interferons; Ipilimumab; Nivolumab; Olaratumab; Pembrolizumab; Trabectedin

Criteria

Inclusion Criteria:

• 18 years of age or over.

• At least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. Tumors should not be selected if the Investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis.

• Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.

• ECOG performance status of 0-2 (or a Karnofsky performance status of >50%)

• Labs required for enrollment (prior to microinjection):

• Absolute neutrophil count > 1000/mm3

• Platelet count > 50,000/mm3

• Hematocrit > 25%

• Creatinine <3.0 mg/dl

• Total Bilirubin <4.0 mg/dl

• Bilirubin <4.0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal

• PT and PTT ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

• Subjects with active fungal, viral, or bacterial infections.

• Pregnant women.

• Inability to give informed consent.

• Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.

• Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.