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

Primary Purpose

Sarcoma, Neoplasms, Connective and Soft Tissue

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Autologous dendritic cell vaccine
Sponsored by
N.N. Petrov National Medical Research Center of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Fibrosarcoma, Neurofibrosarcoma, Histiocytoma, Histiocytoma, Malignant Fibrous, Chondrosarcoma, Synovial Sarcoma, Leiomyosarcoma, Liposarcoma, Myosarcoma, Rhabdomyosarcoma, Sarcoma, Alveolar Soft Part, NY-ESO-1, MAGE, MAGE A3, Vaccine, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • N. N. Petrov Research Institute of oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous dendritic cell vaccine

Arm Description

Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Objective response rate
The percentage of patients whose cancer shrinks or disappears after treatment.
Assess biological response of tumors
Сhanging level of T lymphocytes subpopulation in peripheral blood

Full Information

First Posted
June 17, 2013
Last Updated
November 18, 2019
Sponsor
N.N. Petrov National Medical Research Center of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01883518
Brief Title
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
Acronym
ADCVCTAST
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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. Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use) After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Neoplasms, Connective and Soft Tissue
Keywords
Fibrosarcoma, Neurofibrosarcoma, Histiocytoma, Histiocytoma, Malignant Fibrous, Chondrosarcoma, Synovial Sarcoma, Leiomyosarcoma, Liposarcoma, Myosarcoma, Rhabdomyosarcoma, Sarcoma, Alveolar Soft Part, NY-ESO-1, MAGE, MAGE A3, Vaccine, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous dendritic cell vaccine
Arm Type
Experimental
Arm Description
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
Intervention Type
Biological
Intervention Name(s)
Autologous dendritic cell vaccine
Other Intervention Name(s)
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens, CTA vaccine, DC vaccine, DC CTA vaccine
Intervention Description
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
Primary Outcome Measure Information:
Title
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Median progression-free survival
Description
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
Time Frame
6 month
Title
Median overall survival
Description
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
Time Frame
6 month
Title
Objective response rate
Description
The percentage of patients whose cancer shrinks or disappears after treatment.
Time Frame
6 mounth
Title
Assess biological response of tumors
Description
Сhanging level of T lymphocytes subpopulation in peripheral blood
Time Frame
6 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuriy Komarov, PhD
Organizational Affiliation
N. N. Petrov Research Institute of oncology
Official's Role
Study Chair
Facility Information:
Facility Name
N. N. Petrov Research Institute of oncology
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation

12. IPD Sharing Statement

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Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

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