NCT01883518

Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas

Detailed description

Vaccination is carried out on the planned days ± 3 days 1. All examinations must be performed before the vaccine is administered. * Full physical examination. * Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity. * Evaluation of concomitant therapy. * Assessment of vital signs. * Laboratory safety and immunological indicators * Assessment of adverse events, symptoms and syndromes of the disease. 2. Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use) 3. After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.

Conditions

• Sarcoma
• Neoplasms, Connective and Soft Tissue

Interventions

Type	Name	Description
BIOLOGICAL	Autologous dendritic cell vaccine	Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens

Timeline

• Start date: 2013-06-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2013-06-21
• Last updated: 2019-11-20

Locations

1 site across 1 country: Russia