Status:
UNKNOWN
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Conditions:
Sarcoma
Neoplasms, Connective and Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 c...
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 (bloo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01883518
Start Date
June 1 2013
End Date
September 1 2020
Last Update
November 20 2019
Active Locations (1)
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1
N. N. Petrov Research Institute of oncology
Saint Petersburg, Russia, 197758