CTRI Number	CTRI/2010/091/001232 [Registered on: 14/09/2010]
Last Modified On:	25/07/2014
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Biological
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	Treatment of Recurrent Cervix Cancer ( Following treatment, cancer has returned to the cervix ) with ADXS11-001 (the experimental drug) with and without Cisplatin as 2nd Line Therapy (failed on prior treatment)
Scientific Title of Study Modification(s)	A Randomized, Active Therapy Controlled Phase 2 Study to Assess the Safety and Efficacy of ADXS11-001 with and without Cisplatin as 2nd Line Therapy for the Treatment of Recurrent Cervix Cancer
Secondary IDs if Any Modification(s)	Secondary ID  Registry  Lm-LLO-E7-15  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name    Address    Phone     Fax     Email
Details Contact Person Scientific Query Modification(s)	Name  Dr Atul Gupta  Address  Max Neeman International Address: Max House, 1st Floor 1, Dr. Jha Marg, Okhla Phase-III New Delhi 110020 India South DELHI 110020 India  Phone  91-9717287654   Fax  91-11-41001945   Email  atul.gupta@maxneeman.com
Details Contact Person Public Query Modification(s)	Name  Dr Shariq Anwar  Address  Max Neeman International Max House 1, Dr. Jha Marg, Okhla Phase III New Delhi - 110 020 India South DELHI 11020 India  Phone  91-11-40772100   Fax  91-11-40548168   Email  sanwar@neemanasia.com
Source of Monetary or Material Support Modification(s)	Advaxis, Inc., 305 College Road East, Princeton, NJ 08540, United States.
Primary Sponsor Modification(s)	Name  Advaxis Inc  Address  Advaxis, Inc., 305 College Road East, Princeton, NJ 08540, United States  Type of Sponsor  Pharmaceutical industry-Global
Details of Secondary Sponsor Modification(s)	Name  Address  Max Neeman International  Max Neeman International Max House 1, Dr. Jha Marg, Okhla Phase III New Delhi - 110 020
Countries of Recruitment Modification(s)	India
Sites of Study Modification(s)	No of Sites = 19   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Ajay Sharma  Acharya Tulsi Regional Cancer Treatment and Research Institute  S. P. Medical college and A.G. of Hospitals Pin Code - 334001, India. Bikaner   91-9414140664 0151-2226329 ajaysharmaspmbkn@gmail.com  Dr Sudha Sinha  Bibi General Hospital & Cancer Centre  3-991/1/C, Govt. Printing Press Road, Malakpet-500024, India Hyderabad   91-986222681 91-40-233919622 sudhamd@gmail.com  Dr Ajay Mehta  Central India Cancer Research Institute  P-11, West High Court Road, Shankar Nagar-440010, India Nagpur   91-712-2520956 91-712-2523404 ajayonco@hotmail.com  Dr Kriti Srivastava  Chhatrapati Shahuji Maharaj Medical University  Department of Radiotherapy, Chowk- 226603, India Lucknow   91-9415020601 91-522-2258878 dr.kirti@rediffmail.com  Dr Partha Basu  Chittaranjan National Cancer Institute  37, S. P. Mukherjee Road-700026 Kolkata   91-33-24854345 91-33-24851558 basupartha@hotmail.com  Dr Subhashini John  Christian Medical College  Ida B Scudder Road-632004, India Vellore   91-416-2282046 91-416-2235555 subha@cmcvellore.ac.in  Dr Rajnish Nagarkar  Curie Manavata Cancer Centre  Opp. Hotel Sandeep, Mumbai Naka-422004, India Nashik   91-253-2595666 91-253-2594866 drraj@manavatacancercentre.com  Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  Off Karve Road, Erandwane -411004, India Pune   91-20-66023025 91-20-66023025 drchetandeshmukh@rediffmail.com  Dr Sumana Premkumar  Dr. Kamakshi Memorial Hospital  1, Radial Road, Pallikaranai-600100, India Chennai   91-44-22469200 91-44-22463282 sumana_prem@yahoo.co.in  Dr Senthil Rajappa  Indo American Cancer Institute and Research Centre  Road No. 14, Banjara Hills, Pin Code -500034, India Hyderabad   91-9849213102 91-40-23551235 siddharth142@sify.com  Dr Vijay Kumar  M.V. Hospital & Research Centre  314/30, Mirza Mandi, Chowk -226003, India Lucknow   91-522-2258215 91-522-4079157 drvkumar2007@rediffmail.com  Dr Kirushnakumar  Meenakshi Mission Hospital and Research Centre  Lake Area Melur Road, Pin Code-625107, India Madurai   91-9787713004 91-452-2588471 drkskk@yahoo.com  Dr Vibha Naik  Naik Hospital   Kasar Faliya, Opp. Govt. Press, Kothi Road,Pin Code -390001, India Vadodara   91-9825029085 91-265-2434788 vibhanaik64@yahoo.com  Dr Mridul Gehlot   Narayana Hrudayalaya Hospital  Sector 28, Rana sanga Marg, Pratap nagar, Sanganer, Pin Code -302033, India Jaipur   91-9414044445 drmridulgehlot@yahoo.com  Dr Prakash Dale  Nurgis Dutt Memorial Cancer Hospital  Agalgaon Road, Barshi – 413401, India Solapur   91-9422644526 drpsdale@gmail.com  Dr Minish Jain  Ruby Hall Clinic  40, Sassoon Road - 411001, India Pune   91-9823133390 91-20-66455605 minishjain009@gmail.com  Dr O P Sharma  S. M. S. Medical College and Hospital  Dept. of Radiotherapy, JLN Marg, Pin Code -302004, India Jaipur   91-9829057033 91-141-2502158 dromsharma22@gmail.com  Dr Rakesh Neve  Smt. Kashibai Navale Medical College & General Hospital  49/1. off Westerly Bypass Highway, Narhe (Ambegaon), Pin Code - 411041, India Pune   91-9881143140 91-20-24392311 rakesh.neve@gmail.com  Dr Sudeep Gupta  Tata Memorial Centre  Dr. E. Borges Road, Parel-400012, India Mumbai   91-22-24177000 91-22-24146937 sudeepgupta04@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 19   Name of Committee  Approval Status  Aasha Ethical Committee Naik Hospital, Baroda  Approved  Central India Cancer Research Institute Ethics Committee   Approved  Curie Manwata Clinical Research Institute Professional Ethics Committee  Approved  Deenanath Mangeshkar Hospital & Research Centre, Institutional Ethics Committee  Approved  Ethical Review Board - Meenakshi Mission Hospital and Research Centre   Approved  Ethics committee Acharya Tulsi Regional Cancer Treatment and Research Institute   Approved  Ethics committee S.M.S. medical college  Approved  Human ethics Committee Tata Memorial Centre  Approved  Institutional Ethics committee Bibi General Hospital & Cancer Center   Approved  Institutional Ethics Committee Chhatrapati Shahuji Maharaj Medical University  Approved  institutional Ethics Committee Chittaranjan National Cancer Institute  Approved  Institutional Ethics committee Indo American Cancer Institute and research centre  Approved  Institutional Ethics committee M.V Hospital & Research Centre   Approved  Institutional Ethics Committee Nurgis Dutt Memorial Cancer Hospital  Approved  Institutional Ethics committee Poona Medical Research Foundation   Approved  Institutional Review Board dr. Ida B Scudder Cancer Centre  Approved  Medical Ethics Committee Dr. Kamakshi memorial Hospital  Approved  Sanjeevani Ethics Commitee  Approved  Smt. Kashibai Navale Medical College Ethics Commmittee  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Recurrent Cervix Cancer
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  ADXS11-001  ADXS11-001 is a genetically modified Listeria monocytogenes bacteria expressing Human Papillomavirus type 16 E7 (ADXS11-001) for the treatment of disease associated with Human Papilloma Virus HPV, including Cervical Intraepithelial Neoplasia (CIN) Grades 2 and 3 and cervix cancer and designed for intravenous administration.   Comparator Agent  Cisplatin  None
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Female  Details  1. Female patients 18-60 years of age capable and willing to provide informed consent according to national, state and institutional guidelines indicating that they are aware of the investigational nature of the study, and who agree in writing to comply with the requirements for participation in this study. 2. Patients who are capable of reproduction and agree to take oral contraceptives for the duration of the study are acceptable for entry into this trial. 3. Patients must have documented, recurrent or progressing invasive cervix cancer subsequent to treatment with prior cytotoxic treatment consisting of chemotherapy, radiotherapy or both that is confirmed by CT scan or radiological scan. 4. Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be 20 mm when measured by conventional techniques,recorded). Each lesion must be 10 mm when measured byincluding palpation, plain x-ray, CT, and MRI, or spiral CT. 5. Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. 6. Eastern 2 (Karnofsky IndexCooperative Oncology Group (ECOG) performance status 60%). 7. Patients must have adequate:a. Bone marrow function: Platelet count greater than or equal to 100,000/mcl and ANC count greater than or equal to 1,500/mcl, equivalent to CTCAE v4.0 grade 1.b. Renal function: Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1. c. Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1).d. Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade 1. 8. Only patients with squamous cell carcinoma of the cervix are acceptable for entry into this trial. 9. Patients must respond positively to at least one of the test agents used in the anergy panel described in Appendix D. A positive reaction defined by the formation of a local tissue response of at least 5 mm in sum of the orthogonal measures in reaction to the administration of a delayed hypersensitivity stimulus as described Appendix D is required for patient entry.
ExclusionCriteria	Details  1. Patients with a history of other invasive malignancies, 2. The use of any investigational agent(s) for 28 days prior to dosing with ADXS11-001, 3. The use of any therapeutic agent for the treatment of cervix cancer other than the drugs specified within this protocol during the time a patient is enrolled in this trial will preclude that patient from receiving further study doses. 4. Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervix cancer within the last five years, 5. Patients with brain metastases, 6. Prior biologic therapy, 7. A history of listeriosis, 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, 9. The use of concomitant antibiotics or antibiotics within the past month, 10. Any disease that requires treatment with immunosuppressive drugs. The use of topical corticosteroids and inhaled steroids are not allowed in this study, 11. Hepatitis, cirrhosis, or any other impaired hepatic function as indicated by elevated liver function test serum enzymes. Liver function tests must be within normal range based upon laboratory certification to be allowed into the study. 12. Pregnant women, women actively trying to become pregnant, and nursing women are excluded from this study because ADXS11-001 is a biologic agent with the potential for teratogenic or abortifacient effects. 13. HIV-positive patients are excluded from the study. Patients whose HIV status is not known to the Investigator will be tested to assure HIV negativity. 14. A positive urine test for any drug of abuse, including but not limited to, marijuana, cocaine, and opiates.
Method of Generating Random Sequence Modification(s)	Other
Method of Concealment Modification(s)	Not Applicable
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  To determine the safety and efficacy ADXS11-001 with or without chemotherapy in patients with recurrent or progressing cervix cancer who have failed prior cytotoxic treatment.   1 Year
Secondary Outcome Modification(s)	Outcome  TimePoints  To determine the immuno-stimulatory activity of ADXS11-001 in Patients with recurrent cervix cancer that have failed prior cytotoxic treatment.  1 Year
Target Sample Size Modification(s)	Total Sample Size="110" Sample Size from India="110"
Phase of Trial Modification(s)	Phase 2
Date of First Enrollment (India) Modification(s)	25/11/2010
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial Modification(s)	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details
Brief Summary Modification(s)	This study is designed to assess the safety and efficacy of a vaccine regimen comprised of three doses of ADXS11-001 followed by antibiotics subsequent to each dose compared to accepted standard therapy consisting of cisplatin in patients with advanced cervix cancer who have failed cytotoxic therapy.