Clinical trial NCT01883518: Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
timeFrame: 6 month
Secondary outcomes:
measure: Median progression-free survival
timeFrame: 6 month
measure: Median overall survival
timeFrame: 6 month
measure: Objective response rate
timeFrame: 6 mounth
measure: Assess biological response of tumors
timeFrame: 6 mounth
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: N. N. Petrov Research Institute of oncology
Study officials:
affiliation: N. N. Petrov Research Institute of oncology
name: Yuriy Komarov, PhD
role: STUDY_CHAIR
References: