Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01883518
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2013-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADCVCTAST
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: