Melanoma Clinical Trial
Official title:
An Open-label Study of the Safety and Efficacy of Tag-7 Gene-modified Tumor Cell-based Vaccine in Patients With Locally Advanced or Metastatic Malignant Melanoma or Renal Cell Cancer
Verified date | November 2019 |
Source | N.N. Petrov National Medical Research Center of Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed to assess the safety and efficacy of inactivated tumor cells genetically modified with the TAG-7 gene as immunotherapy for cancer. Patients with melanoma or kidney cancer were included since they have immune-dependent tumors. Treatment was done in the adjuvant setting after complete cytoreduction of locally advanced or metastatic disease or in the therapeutic setting in patients where complete cytoreduction was impossible.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Signed inform consent form. 2. Patients age = 18 years of age at the time of informed consent. 3. Ability to provide and understand written informed consent prior to any study procedures. 4. Histologically confirmed locally advanced or metastatic MM or RCC. 5. Tumor cell culture should be obtained and successfully transfected before inclusion. 6. No evaluable therapy with a proved survival advantage in the current patient setting. 7. The life expectancy of > 3 months as estimated by the investigator 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 -2 at Screening. Exclusion Criteria: 1. Patient with any out-of-range laboratory values defined as: - Serum creatinine > 1.5 × upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minute - Total bilirubin > 2.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN - Alanine aminotransferase > 2.5 × ULN - Aspartate aminotransferase > 2.5 × ULN - Absolute neutrophil count < 1.5 × 109/L - Platelet count < 100 × 109/L - Hemoglobin < 80 g/L (blood transfusions permitted) 2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies 3. Any clinically significant unstable disease 4. Presence of symptomatic or untreated central nervous system (CNS) metastases 5. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug 6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection 8. Malignant disease, other than that being treated in this study 9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable 10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) |
Country | Name | City | State |
---|---|---|---|
Russian Federation | N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department | St. Petersburg |
Lead Sponsor | Collaborator |
---|---|
N.N. Petrov National Medical Research Center of Oncology | Institute of Gene Biology Russian Academy of Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events rate | CTC AE v.3 was used for safety assesment | From the fist injection to 3 month after the last injection | |
Secondary | Response rate | To assess the objective response rate (OR) RECIST v1.1 and irRC were used at the final assesment | every 8 weeks until disease progression or therapy completion, then every 3 month for 2 years, every 6 month for the next 2 years and annually thereafter | |
Secondary | Concentration of MICA in patient's cultures supernatants | Factor production by culture of patient's tumor cells, used for vaccine preparation | Samples obtained before therapy start | |
Secondary | Concentration of TGF-ß1 in patient's cultures supernatants | Factor production by culture of patient's tumor cells, used for vaccine preparation | Samples obtained before therapy start | |
Secondary | Concentration of IL-10 in patient's cultures supernatants | Factor production by culture of patient's tumor cells, used for vaccine preparation | Samples obtained before therapy start | |
Secondary | Concentration of VEGF in patient's cultures supernatants | Factor production by culture of patient's tumor cells, used for vaccine preparation | Samples obtained before therapy start | |
Secondary | Number of T-cells in peripheral blood of patients | Absolute (10^9/L) of CD3+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of T-helper lympocytes in peripheral blood of patients | Absolute (10^9/L) concentration of CD4+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of Cytotoxic lymphocytes in peripheral blood of patients | Absolute (10^9/L) concentration of CD8+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of NK-lymphocytes in peripheral blood of patients | Absolute (10^9/L) concentration of CD16+CD56+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of CD38+ cells in peripheral blood of patients | Absolute (10^9/L) concentration of CD38+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of HLA-DR+ cells in peripheral blood of patients | Absolute (10^9/L) concentration of HLA-DR+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of CD71+ cells in peripheral blood of patients | Absolute (10^9/L) concentration of CD71+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of B-lymphocytes cells in peripheral blood of patients | Absolute (10^9/L) concentration of CD71+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Number of CD25+ cells in peripheral blood of patients | Absolute (10^9/L) concentration of CD25+ cells in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | IgA level | IgA (g/L) level in serum | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | IgG level | IgG (g/L) level in serum | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | IgM level | IgM (g/L) level in serum | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Spontaneous lymphocytes migration | Lymphocytes migration (U) without stimulation | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Kon-A stimulated migration | Lymphocyte migration after in vitro stimulation with Kon A (% inhibition of migration) | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | PGA stimulated migration | Lymphocyte migration after in vitro stimulation with PGA (% inhibition of migration) | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Ingestion rate of monocytes | Ingestion rate (%) | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Ingestion rate of neutrophils | Ingestion rate (%) | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) | |
Secondary | Circulating immune complex level | Immune complexes (U) in peripheral blood | 1-5 days before each therapy cycle during course of therapy (cycle 21 days) through therapy completion, an average of 6 cycles (18 weeks) |
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