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Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma — ADCVCTAST  

Sarcoma Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Neoplasms, Connective and Soft Tissue
  • Sarcoma
Clinical Trial Details
NCT number NCT01883518
Study type Interventional
Source N.N. Petrov National Medical Research Center of Oncology
Contact
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date June 2013
Completion date September 2020
View Details
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