Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

Sarcoma Clinical Trial

— ADCVCTAST  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01883518
• Other study ID #: MC-01-2013
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: June 2013
• Est. completion date: September 2020

Study information

• Verified date: November 2019
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Connective and Soft Tissue
• Sarcoma

Intervention

Biological:
• Autologous dendritic cell vaccine
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens

Locations

Country	Name	City	State
Russian Federation	N. N. Petrov Research Institute of oncology	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas	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	6 month
Secondary	Median progression-free survival	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works	6 month
Secondary	Median overall survival	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works	6 month
Secondary	Objective response rate	The percentage of patients whose cancer shrinks or disappears after treatment.	6 mounth
Secondary	Assess biological response of tumors	?hanging level of T lymphocytes subpopulation in peripheral blood	6 mounth