Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma (ADCVCTAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Petrov Research Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01883518
First received: June 17, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Sarcoma
Neoplasms, Connective and Soft Tissue
Biological: Autologous dendritic cell vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Petrov Research Institute of Oncology:

Primary Outcome Measures:
  • Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 6 mounth ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 6 mounth ] [ Designated as safety issue: Yes ]
    Grade of Allergic reaction/hypersensitivity, Autoimmune reaction, Fever, Injection site reaction by CTCAE v 4.0

  • Assess biological response of tumors [ Time Frame: 6 mounth ] [ Designated as safety issue: No ]
    Сhanging level of T lymphocytes subpopulation in peripheral blood


Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883518

Contacts
Contact: Yury Komarov, MD 4399505 ext +7812 anofelesof@gmail.com

Locations
Russian Federation
Petrov Research Institute of Oncology Recruiting
Saint-Petersburg, Russian Federation, 197758
Contact: Yury Komarov, MD    4399505 ext +7812    anofelesof@gmail.com   
Principal Investigator: Yury Komarov, MD         
Sponsors and Collaborators
Petrov Research Institute of Oncology
  More Information

No publications provided

Responsible Party: Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT01883518     History of Changes
Other Study ID Numbers: MC-01-2013
Study First Received: June 17, 2013
Last Updated: June 19, 2013
Health Authority: Russia: Ethics Committee
Russia: The Ministry of Education and Science of the Russian Federation
Russia: Ministry of Health of the Russian Federation

Keywords provided by Petrov Research Institute of Oncology:
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

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Sarcoma
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014