APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 10
Summary
- Conditions
- Recurrent Colorectal Carcinoma
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Solid Neoplasm
- Unresectable Solid Neoplasm
- Recurrent Pancreatic Carcinoma
- Recurrent Solid Neoplasm
- Stage IV Colorectal Cancer
- Stage IV Pancreatic Cancer
- Stage IVA Colorectal Cancer
- Stage IVA Pancreatic Cancer
- Stage IVB Colorectal Cancer
- Stage IVB Pancreatic Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN40...
PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival. OUTLINE: Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.
Tracking Information
- NCT #
- NCT03087591
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Pierre Triozzi Wake Forest University Health Sciences
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