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

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ClinicalTrials.gov Identifier: NCT01883518
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2013
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


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




Primary Outcome Measures :
  1. Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas [ Time Frame: 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 :
  1. Median progression-free survival [ Time Frame: 6 month ]
  2. Median overall survival [ Time Frame: 6 month ]
  3. Objective response rate [ Time Frame: 6 mounth ]
  4. Assess biological response of tumors [ Time Frame: 6 mounth ]
    Сhanging level of T lymphocytes subpopulation in peripheral blood



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883518


Locations
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Russian Federation
Petrov Research Institute of Oncology
Saint-Petersburg, Russian Federation, 197758
Sponsors and Collaborators
N.N. Petrov National Medical Research Center of Oncology

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Responsible Party: N.N. Petrov National Medical Research Center of Oncology
ClinicalTrials.gov Identifier: NCT01883518     History of Changes
Other Study ID Numbers: MC-01-2013
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Keywords provided by N.N. Petrov National Medical Research Center 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:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs