Health Condition 1: null- Cancer
Conditions
Interventions
Intervention1: APCEDEN?: Each dose of APCEDEN? will consist of dendritic cells approximately 1 million in 15ml administered as intravenous infusion. 6 doses are given every 2 weeks for first 3 cycl
Sponsors
APAC BIOTECH PVTLTD
Semler Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects from 18 to 70 years of age 2.Histologically confirmed refractory solid tumors on symptomatic care 3.Available tumor tissue: embedded in paraffin blocks and/or unstained slides 4.Life expectancy at least 3 months 5.ECOG status less than 2 6. Adequate Organ function: A. Liver function: i. In the absence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 2 times ULN ii. In the presence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 5 times ULN iii. Alkaline phosphatase less than equal to 2.5 times ULN iv. Albumin more than equal to 3.0 g/dL B. Renal function: i. Serum creatinine less than equal to 1.5 times ULN ii. No active acute or chronic urinary tract infection iii. Urinalysis with no evidence of proteinuria C. Hematology Status: i. Platelet count more than equal to 100,000 platelet/cumm (100 ×109/L) ii. Hemoglobin more than equal to 9 g/dL. iii. WBC more than equal to 3,000/cumm D. Coagulation Profile: i. Acceptable coagulation profile (PT or INR, PTT) less than 1.5 times ULN E. Serum immune-globulins IgA and IgM within normal range 7. No blood transfusion within 4 weeks of joining the study. 8. No exposure to immunotherapy and cancer Immunotherapy 9. Females of child bearing potential must have negative urine pregnancy test at screening 10. Child bearing potential participants to exercise effective birth control measures 11. Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site.
Exclusion criteria
Exclusion criteria: 1. Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment 2. Exposure to any investigational agent within 30 days of the Screening Visit. 3. Central Nervous System Metastases 4. Known Autoimmune disease or disease process that involves the use of immunosuppressive therapy 5. Patients on long-term steroid therapy (more than one week) 6. Underlying Cardiac disease associated with New York Heart Association Class III and IV function or unstable angina related to atherosclerotic cardiovascular disease 7. Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis 8. Known HIV infection 9. Active Hepatitis 10. Active Tuberculosis 11. Any Uncontrolled active, infection. 12. Substance abuse or any condition that might interfere with the subject?s participation in the study or in the evaluation of the study results. 13. History of hypersensitivity to Immunotherapy such as asthma, anaphylaxis or other severe reactions 14. Any medical, psychological, sociological or geographical constraints judged by the investigator that would impede patients compliance to the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and Tolerability 2. Response As per RECIST criteria and irRC Timepoint: Baseline, Day 9, day 54, day 100, day184 and end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess Quality of Life (QOL) as measured by the FACT-G (Functional Assessment of Cancer Therapy-General). 2. Change in immune response by measuring following parameters pre and post APCEDENâ?¢ therapy by flow cytometry: i. Peripheral Blood CD4+ and CD8+ count ii. Activity of Natural Killer Cells in peripheral blood iii. IFN-Gamma 3. Time to Treatment Progression (TTP) Timepoint: Baseline, Day 9, day 54, day 100, day184 and end of trial | — |
Countries
India
Contacts
Public ContactRajesh Radhakrishnan
Outcome results
None listed