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1 Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr :11:00 GMT) CTRI Number Last Modified On 04/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/07/ [Registered on: 26/07/2011] - Trial Registered Prospectively No Interventional Other (Specify) [immunotherapy] Single Arm Trial APCEDEN (Autologous Dendritic Cell Therapy) In Refractory Solid Tumors. An open label, multi-centre, non-randomized, single arm study to evaluate the safety and efficacy of APCEDEN [Dendritic Cell (DC) immunotherapy] in patients with refractory solid malignancies, on symptomatic treatment. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) AP/111/11 Designation Affiliation Protocol Number Details of Principal Investigator Dr P P Bapsy Phone Fax Designation Affiliation Senior Consultant Medical Oncology Apollo Hospital Bannerghatta Road ppbapsy@yahoo.com Details Contact Person (Scientific Query) Dr P P Bapsy Phone Fax Designation Affiliation Sponsor Therapeutic Expert Apollo Hospital Bannerghatta Road ppbapsy@yahoo.com Details Contact Person (Public Query) Rajesh Radhakrishnan Associate Project Manager Phone Fax Semler Research Center Pvt. Ltd. 75A, 15th cross,1st phase J.P Nagar, page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > APAC BIOTECH PVTLTD Type of Sponsor Semler Research Center List of Countries of Principal Investigator Dr VS Suresh Attili Dr Senthil Rajappa Source of Monetary or Material Support Primary Sponsor Details APAC BIOTECH PVTLTD 69, Jacarandamarg, DLF Phase II, Gurgaon, Haryana. INDIA Other [Biotech company] Semler Research Center Pvt Ltd 75A, 15th Cross, I Phase J.P.Nagar, , INDIA Tel : ;Ext. 289 Fax: ; of Site Site Phone/Fax/ Bibi General Hospital and Cancer Centre Indo American Cancer Institute /1/C,Governm ent Priniting Press Roa d,malakpet,hyderabad Hyderabad ANDHRA PRADESH Medical Oncology Department, Road No.14, Banjara Hills,Hyderabad Hyderabad ANDHRA PRADESH Dr Ashok Kumar Vaid Medanta The Medicity Medanta The Medicity,Sector 38, Gurgaon , Harayana North DELHI Dr Bharath Rangarajan Narayana Hrudayalaya Medical Oncology Department, No.258/A, Bommasandra Industrial Area, Anekal Taluk. Dr Minish Jain Ruby Hall Clinic 40, Sassoon Road, Pune , Maharashtra, Pune MAHARASHTRA Dr Shyam Aggarwal Sir Gangaram Hospital Medical Oncology Department, Rajinder Nagar, New Delhi North DELHI Dr Kumar Prabhash Tata Memorial Hospital Medical Oncology Department, Dr. E sureshattili@yahoo.com mvr2mvr@gmail.com akvaid@yahoo.com bharath37@gmail.com minishjain009@gmail.c om drshyam_aggarwal@ya hoo.com page 2 / 6

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Dr Sundaram Subramanian V S Hospital Borges Road, Parel, Mumbai Mumbai MAHARASHTRA Medical Oncology Department, No.13,E Spur Tank Rd,Chetpet, Chennai Chennai TAMIL NADU kp_prabhash@rediffmai l.com clinicalresearch.vsh@g mail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Basavatarakam Indo American Cancer Hospital and Research Institute Ethics Committee,Road No.14, Banjara Hills,Hyderabad Ethics Committee Poona Medical Research Foundation/P une/dr.minish Jain, 40, Sassoon Road, Pune Approved 03/08/2011 No Approved 25/10/2011 Yes Institutional Ethics committee Bibi General Hospital and Cancer Ce ntre, /1/c,gove rnment Priniting Press Road,Malakpet,Hydera bad Approved 24/10/2011 No Madras Clinical Research Center, V.S Hospital, No.13,East Spur Tank Road,Chetp et,chennai Medanta Institutional Review Board, Sector 38, Gurgaon , Harayana Narayana Hrudayalaya Medical Ethics Committ ee,bommasandra Industrial Area, Anekal Taluk,, Sir Gangaram Hospital Ethcis Committee,Rajinder Nagar, New Delhi Approved 22/09/2011 No Approved 31/10/2011 Yes Approved 16/07/2011 No Approved 18/10/2011 No Tata Memorial Hospital Ethics Committee, Dr. E Borges Road, Parel, Mumbai , Approved 14/12/2011 No Status Date page 3 / 6

4 Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Notified 01/07/2011 Health Type Patients Condition Cancer Type Details Intervention 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 cycles and next 3 cycles are given every 3 weeks.total duration of the treatment is about 4 months Comparator Agent Age From Age To Gender Details Year(s) Year(s) Both 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 09/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 page 4 / 6

5 trial procedures, and have accessibility to the site. Exclusion Criteria Details 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 subjects 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 Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints 1. Safety and Tolerability 2. Response As per RECIST criteria and irrc Baseline, Day 9, day 54, day 100, day184 and end of trial Secondary Outcome Outcome Timepoints 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 APCEDEN 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) Baseline, Day 9, day 54, day 100, day184 and end of trial Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Total Sample Size=50 Sample Size from =50 14/09/2011 page 5 / 6

6 Powered by TCPDF ( Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified Years=1 Months=0 Days=0 Completed The study is to evaluate safety and efficacy of APCEDEN (Dendritic cell (DC) immunotherapy], an autologous cell-based cancer therapy consisting of live dendritic cells along with cytokines. The study population consists of patients with stage IV refractory solid tumors. The study includes about 4 months of treatment and 3 months of post treatment follow-up. The patients will receive 6 doses of APCEDEN given every 2 weeks for first 3 cycles and next 3 cycles given at an interval of every 3 weeks. In addition to the screening visit, there will be a minimum of 9 visits for the entire study duration. A total of 50 patients will be enrolled in the study from 8-10 centers across. Result: 65 patients were screened from 6 sites across, 53 were enrolled (underwent apheresis) and 51 received at least one dose of the vaccine. 38 patients underwent one response evaluation visit and were considered evaluable. 13 out of 51 patients could not undergo response evaluation visit and were therefore only evaluated for safety. However five patients out of the 13 non evaluable cases 5 were clinically evaluated at the time of withdrawal from trial and their Best Overall Response (BOR) was captured. All 51 cases were evaluated for safety. In all 218 infusions were administered and all were tolerated barring only one instance of chills and rigors associated with mild pyrexia reported during a single infusion. The patient continued on the study, symptoms were resolved and did not reappear during subsequent infusions. According to investigator it could have been possibly related to study therapy. 21.6% of the patients reported SAEs. None of the SAEs were related to study therapy. page 6 / 6