Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma (ADCVCTAST)

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

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

Study Overview

• Status: Unknown
• Conditions: Sarcoma; Neoplasms, Connective and Soft Tissue
• Intervention / Treatment: Biological: Autologous dendritic cell vaccine

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 197758
    • N. N. Petrov Research Institute of oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous dendritic cell vaccine; Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens	Biological: Autologous dendritic cell vaccine; Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens; Other Names: Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens; CTA vaccine; DC vaccine; DC CTA vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas	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	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median progression-free survival	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	6 month
Median overall survival	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	6 month
Objective response rate	The percentage of patients whose cancer shrinks or disappears after treatment.	6 mounth
Assess biological response of tumors	Сhanging level of T lymphocytes subpopulation in peripheral blood	6 mounth

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Chair: Yuriy Komarov, PhD, N. N. Petrov Research Institute of oncology

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Vaccine; Immunotherapy; Rhabdomyosarcoma; NY-ESO-1; MAGE; Leiomyosarcoma; Liposarcoma; Chondrosarcoma; Synovial Sarcoma; Fibrosarcoma; Neurofibrosarcoma; Histiocytoma; Histiocytoma, Malignant Fibrous; Myosarcoma; Sarcoma, Alveolar Soft Part; MAGE A3
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Connective and Soft Tissue; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MC-01-2013