Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

The Republican Research and Practical Center for Epidemiology and Microbiology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dendritic Cells; Pancreatic Neoplasms

Treatments: Biological: Dendritic cells pulsed with tumor lysate; Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT03114631

RRPCEM_DC1

Details and patient eligibility

About

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Full description

The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
• HLA-A2 expression by tumor cells;
• WT-1/MUC-1 expression by tumor cells.

Exclusion criteria

• refuse of patient to participate in the trial;
• pregnancy/lactation;
• intercurrent severe chronic diseases;
• HIV, Hepatites B/C;
• active tuberculosis;
• alcohol use disorder/drug addiction.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Dendritic cells lysate-pulsed group

Experimental group

Description:

Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate

Treatment:

Biological: Dendritic cells pulsed with tumor lysate

Control group

No Intervention group

Description:

Patients treated according to clinical protocols

Dendritic cells peptide-pulsed group

Experimental group

Description:

Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides

Treatment:

Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides