Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

Phase 1

• Conditions: Sarcoma; Neoplasms, Connective and Soft Tissue

• Registration Number: NCT01883518
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• age of 18 or older
• ECOG performance score 0 or 1
• Histologically proven soft tissue sarcoma
• Unresectable or metastatic soft tissue sarcoma
• Ability to give written informed consent
• Objective measured and measurable tumor lesions
• The failure of standard therapy
• Adequate amount of material for genetic research
• No active or chronic infection with HIV, Hepatitis B or Hepatitis C
• Men/Women of childbearing potential must use adequate contraception
• Hematology, liver function and renal function lab tests within required parameters

Exclusion Criteria

• Untreated or uncontrolled brain metastases.
• History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
• Autoimmune disease (vitiligo is not a basis for exclusion).
• Serious uncontrolled medical disorder or active infection that would impede treatment.
• Underlying medical or psychiatric condition that would cause administration vaccine
• Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
• Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
• Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
• Pregnant or breastfeeding women.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas	6 month	Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas

Secondary Outcome Measures

Name	Time	Method
Median overall survival	6 month	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works
Median progression-free survival	6 month	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works
Objective response rate	6 mounth	The percentage of patients whose cancer shrinks or disappears after treatment.
Assess biological response of tumors	6 mounth	Сhanging level of T lymphocytes subpopulation in peripheral blood

Trial Locations

Locations (1)

N. N. Petrov Research Institute of oncology; 🇷🇺 Saint-Petersburg, Russian Federation