| CTRI Number |
CTRI/2010/091/001348 [Registered on: 24/11/2010] |
| Last Modified On: |
16/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF PT 107 (VACCINE) IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS |
Scientific Title of Study
Modification(s)
|
PHASE II CLINICAL TRIAL OF IMMUNOTHERAPY WITH AN ALLOGENEIC B7.1/HLA-A1 TRANSFECTED TUMOR CELL VACCINE (PT 107) IN PATIENTS WITH STAGES IIIB/IV NON-SMALL CELL LUNG CANCER THAT HAVE COMPLETED FIRST LINE CHEMOTHERAPY |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PT 107-2009-01 Ver 1.1, 4 Mar 2011 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Varada Bidargaddi |
| Designation |
Director Operations and Medical Affairs |
| Affiliation |
Director Operations |
| Address |
Kentron Biotechnology, No. 68, 1st Floor, 15th Cross, RT Nagar, Bangalore
1st Block, R. T. Nagar
Bangalore
KARNATAKA
560032
India |
| Phone |
08023630763 |
| Fax |
08023631763 |
| Email |
varada.bidargaddi@kentron.co |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Varada Bidargaddi |
| Designation |
Director Clinical Operations and Medical Affairs |
| Affiliation |
Kentron Biotechnology Pvt Ltd |
| Address |
No. 68, 1st Floor, 15th Cross
1st Block, R. T. Nagar
Bangalore
KARNATAKA
560032
India |
| Phone |
080-23630763 |
| Fax |
080-23631763 |
| Email |
varada.bidargaddi@kentron.co |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Varada Bidargaddi |
| Designation |
Director Operations and Medical Affairs |
| Affiliation |
Director Operations |
| Address |
Kentron Biotechnology, No. 68, 1st Floor, 15th Cross, RT Nagar, Bangalore
1st Block, R. T. Nagar
Bangalore
KARNATAKA
560032
India |
| Phone |
08023630763 |
| Fax |
08023631763 |
| Email |
varada.bidargaddi@kentron.co |
|
Source of Monetary or Material Support
Modification(s)
|
| PIQUE THERAPEUTICS, INC.
2350, MERIDIAN PARKWAY, SUITE 200
DURHAM, NC27713, USA. |
|
Primary Sponsor
Modification(s)
|
| Name |
PIQUE THERAPEUTICS INC |
| Address |
2350, MERIDIAN PARKWAY, SUITE 200DURHAM, NC27713, USA. |
| Type of Sponsor |
Other [Biopharmaceutical Company] |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Kentron Biotechnology Private Limited |
68,1st Floor,1st Block
15th Cross RT Nagar
Bangalore-560032
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiv Prasad Shrivastava |
Choithram Hospital & Research Centre |
Depatartment of Radioation Oncology, Ground floor, Manik Bagh Road,-452 014
Indore
MADHYA PRADESH |
91-9669266007
91-731-2470068
drsp2001@yahoo.com |
| DrVenkateshan Srinivasan |
Dr Kamakshi Memorial Hospital Pvt Ltd. |
Department of Medical Oncology, Cellar, Dr. Kamakshi Hospital, No-1, Radial Road, ,Pallikaranai-600100
Chennai
TAMIL NADU |
91-9566242001
91-44-22643282
vsrinivasan09@gmail.com |
| Dr Rajesh Kumar Singh |
Indira Gandhi Institute of Medical Sciences |
Department of Medical Oncology, regional cancer center, IGIMS, Sheikhpura,-800 014
Patna
BIHAR |
91-9939088899
91-612-2297225
drrajeshsingh@yahoo.com |
| Dr Gorijavolu Durga Prasad |
Indo-American Cancer Institute & Research Centre |
Department of Radiation Oncology, Room no. 2, Cellar, Indo American Hospital, Road #14,Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
91-9848212569
91-40-23542120
durgaoncodr@yahoo.co.uk |
| Dr Basavaraj Patil |
Karnatak Cancer Therapy and Research Institute (KCTRI) |
Room number 2, first floor, near blood bank, Padmashree Dr. RB Patil Cancer Hospital,Navanagar-580 025
|
91-9448122258
91-836-2322063
basupatil@hotmail.com |
| Dr Vijay Kumar |
M.V. Hospital & Research Centre |
Consultation room, First floor, MV Hospital, Mirza Mandi Chowk,-226 003
Lucknow
UTTAR PRADESH |
91-9935383666
91-522-4016051
drvkumar2007@rediffmail.com |
| Dr Yathish Kumar |
N. R. R. Hospital |
Department of Medical Oncology, Ground Floor, NRR Hospital, No.3&3A, Hesarghatta Main Road, Chikkasandra
Next to Janapriya Apartments, Near Chikkabanavara Railway Station
Bangalore-560 090.
Bangalore
KARNATAKA |
91-9880462912
080-28375587
dryathish@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, Affiliated to Choithram Hospital & Research Centre |
Approved |
| Ethics Committee, Affiliated to Dr. Kamakshi Memorial Hospital Private Limited |
Approved |
| Ethics Committee, Affiliated to Indo-American Cancer Institute & Research Centre |
Approved |
| Ethics Committee, Affiliated to Karnatak Cancer Therapy & Research Institute |
Approved |
| Human Ethics Committee, Affiliated to Regional Cancer centre, Thiruvananthapuram |
Approved |
| Institutional Ethics Committee, Affiliated to Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Affiliated to MV Hospital |
Approved |
| Nagpur Independent Ethics Committee, Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Advanced non-small cell lung cancer (Stages IIIB/IV) who have failed first line of chemotherapy, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Allogeneic B7.1/HLA-A1 Transfected NSCLC Tumor Cell Vaccine |
0.5ml of Vaccine administered through intradermal injection. Will be given total 9 vaccinations once in every 14 days |
| Comparator Agent |
Placebo (composed of sterile saline containing 0.5% human serum albumin and 10% DMSO without cells) |
0.5ml placebo administered through intradermal injection. Will be given total 9 vaccinations once in every 14 days |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patients with documented stage IIIB or IV advanced or metastatic NSCLC who have completed 4-6 cycles of platinum based chemotherapy, with or without radiation, and have either stable disease or have experienced disease progression (additional prior adjuvant chemotherapy is permitted).
2. ECOG performance status 0-2.
3. Presence of at least one measurable lesion according to RECIST criteria.
4. Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.
5. Pulmonary Function Requirements
All patients will undergo evaluation of pulmonary function prior to enrollment. Patients should have a FeV1 more than 30% of the predicted value and/or DLCO more than 30% of the predicted value with a PCO2 < 45mm. Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, CHF or PE) will have request PFT evaluation and if the above parameters are not fulfilled will be excluded from the protocol.
6. Age > or = 18 years.
7. Signed informed consent.
8. ANC > or =1000/mm3; PLT> or = 80,000/mm3.
9. Hemoglobin > or = 10 g/dL. |
|
| ExclusionCriteria |
| Details |
1. Small cell carcinoma of the lung.
2. Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
3. Other active malignancies present within the past three years, except for basal and / or squamous cell carcinoma(s) or in situ cervical cancer.
4. Concomitant steroid or other immunosuppressive therapy.
5. Active infection, or less than 7 days since therapy for acute infections.
6. Pericardial effusion.
7. Currently receiving chemotherapy for another condition (such as arthritis).
8. Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
9. Pregnant or lactating women (negative test for pregnancy required of women of child bearing potential).
10. Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
11. Known HIV infection.
12. Untreated or uncontrolled brain metastasis.
13. ASL or ALT > or = 2.5 times the upper limit of normal (ULN).
14. Alkaline Phosphatase > or = 5 times ULN. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine whether patients with advanced or metastatic non-small cell lung cancer (stages IIIB/IV) who have failed previous platinum-based chemotherapy (with or without radiation) have an increase in overall survival as a result of vaccination with PT 107. |
From the date of randomization to the recorded date of death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Safety profile of the PT 107. 2. Time to disease progression in patients immunized with PT 107 vaccine as compared to placebo. |
1. Monitored for safety throughout the study. 2. 1st assessment at 13th week and follow-up assessment on 18th week |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
07/03/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, placebo controlled multi-centric trial to determine the safety and efficacy of the PT 107 vaccine in patients with non-small cell lung carcinoma (with stages IIIB & IV). Study will be conducted at 9 centers in India. The primary outcome measures will be to determine the overall survival rate in the patients who have failed previous platinum based chemotherapy. The secondary outcome measures will be to check the safety profile of PT 107 and time to disease progression in patients immunized with PT 107 vaccine as compared to placebo. |