Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
NCT ID: NCT01883518
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2013-06-30
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous dendritic cell vaccine
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
Autologous dendritic cell vaccine
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
Interventions
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Autologous dendritic cell vaccine
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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N.N. Petrov National Medical Research Center of Oncology
OTHER
Responsible Party
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Principal Investigators
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Yuriy Komarov, PhD
Role: STUDY_CHAIR
N. N. Petrov Research Institute of oncology
Locations
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N. N. Petrov Research Institute of oncology
Saint Petersburg, , Russia
Countries
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Other Identifiers
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MC-01-2013
Identifier Type: -
Identifier Source: org_study_id
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