| CTRI Number |
CTRI/2009/091/000664 [Registered on: 25/09/2009] |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Study of Mycobacterium w in BCG refractory Superficial Transitional Cell Carcinoma of Bladder |
Scientific Title of Study
Modification(s)
|
Open label, single arm, exploratory phase I clinical Trial to evaluate efficacy and safety of Mycobacterium w (Mw) in BCG refractory Superficial transitional cell carcinoma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CR-80/8230 |
Protocol Number |
| NCT00694798 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mahesh Desai |
| Designation |
Chaieman, Dept of urology |
| Affiliation |
Muljibhai Patel Urological Hospital, |
| Address |
Muljibhai Patel Urological Hospital,Dr. Virendra Desai Road,
Kheda
GUJARAT
387 001
India |
| Phone |
02682520323 |
| Fax |
02682520248 |
| Email |
mrdesai@mpuh.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepak Sawhney |
| Designation |
Head BA/BE & CR |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
1389, Trasad Road, Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
02714-221481 |
| Fax |
02714-221848 |
| Email |
deepak.sawhney@cadilapharma.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepak Sawhney |
| Designation |
Head BA/BE & CR |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
1389, Trasad Road, Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
02714-221481 |
| Fax |
02714-221848 |
| Email |
deepak.sawhney@cadilapharma.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| CADILA PHARMACEUTICALS LTD.
1389, Trasad Road, Dholka, Ahmedabad- 387810 |
|
Primary Sponsor
Modification(s)
|
| Name |
CADILA PHARMACEUTICALS LTD |
| Address |
Sarkhej – Dholka Road, Bhat, Ahmedabad – 382 210, (Gujarat – India) Phone : +91-2718-225001 Fax: +91-2718-225039 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Ketan Shukla |
Aarogyam speciality hospital |
Soham - I, Nr. Navrang School, Darpan six roads,,Navrangpura-380014
Ahmadabad
GUJARAT |
079-26463535
079-3293022
ketanshukla@hotmail.com |
| Dr. B. R. Shrivastav |
Cancer Hospital and Research Institute |
Jan Vikas Nyas,Mandre ki Mata-474 009
Gwalior
MADHYA PRADESH |
0751 ? 2336502
0751 - 2336506
br_shrivastav08@yahoo.com |
| Dr. Sushil Bhatia |
Choithram Hospital & Research Centre |
Choithram Hospital & Research Centre, Manik Bagh Road, ,Indore- 452 014 (M.P.) -452 014
Indore
MADHYA PRADESH |
0731- 2362491-99
0731 - 2470068
drsushilbhatia@rediffmail.com |
| Dr. Kim Mammen |
Christian Medical College |
Christian Medical College, Ludhiana ? 141 008 (Punjab) ,-141 008
Ludhiana
PUNJAB |
0161 ? 5026999
0161 ? 2609958
kjmammen@gmail.com |
| Dr. Rasesh Desai |
Desai Urological & Maternity Hospital |
2nd & 3rd floor, Abhinav Complex, Kamal Kunj Society,Delux Circle, Nijampura-390 002
Vadodara
GUJARAT |
0265 ? 2780878
0265 - 2780879
raseshdesai61@hotmail.com |
| Dr Rajeev Sood |
Dr. R M LHospital & PGIMER, New Delhi |
Dept Of urology, Room no. 31, Ground floor, OPD building, Dr R M L hospital & PGIMER, New Delhi
New Delhi
DELHI |
9810005182
01123360067
drsoodr@yahoo.com |
| Dr. Kapil Thakkar |
Excel Hospital |
8-15, 3rd floor, Sheetal Shopping Square (Old L. B. Cinema),Ghod dod- Bhatar Road Junction-
Surat
GUJARAT |
0261 ? 2236036
0261 ? 2236036
kapilthakkar@gmail.com |
| Dr. Gaurang Gandhi |
Gandhi Urocare |
312-313, Span Trade centre, 3rd floor,Opp. Kocharab Ashram, Paldi-380 006
Ahmadabad
GUJARAT |
079 ? 26580438
079 - 66314602
gandhi.gaurava@yahoo.com |
| Dr P K Puri |
Indira gandhi Hospital, Shimla |
Dept of urology, Indira Gandhi Hospital, Shimla
Shimla
HIMACHAL PRADESH |
094181476643
puroshotampuri@yahoo.co.in |
| Dr. Anup Kundu |
Institute of Post Graduate Medical Education & Research |
S. S. K. M. Hospital,244, A.J. C Road -700 020
Kolkata
WEST BENGAL |
033 ? 22236287
033 - 22236287
drkundu@rediffmail.com |
| Dr Krishna Moorthy |
Lourdes Hospital |
Kochi-682012
Ernakulam
KERALA |
9847056690
04842393720
dr.moorthy65@gmail.com |
| Dr Mahesh Desai |
Muljibhai Patel Urological Hospital |
Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, ,Nadiad ? 387 001 (Gujarat) -387 001
|
0268 ? 2520323
0268 ? 2520248
mrdesai@mpuh.org |
| Dr. Shrawan K Singh |
Post Graduate Institute of Medical Education and Research |
,-160 012
Chandigarh
CHANDIGARH |
0172 - 2756321
0172 - 2744401
shrawanksingh2002@yahoo.com |
| Dr. Amilal Bhat |
S. P. Medical College & A. G. of Hospitals |
Room No. 13, S. P. Medical College & A. G. of Hospitals,,Bikaner- 334 003 (Raj.) -334 003
Bikaner
RAJASTHAN |
0151 - 2226329
0151 ? 2226329
amilalbhat@rediffmail.com |
| Dr. Ketan Rajyaguru |
Siddhivinayak Hospital, |
A-101/104, Silver Brook, Opp. Doctor House, ,Near Parimal Crossing, Ambavadi-380 010
Ahmadabad
GUJARAT |
079 - 26580438
079 - 26401390
ketanguru@yahoo.com |
| Dr. Jitendra Amlani |
Urocare Hospital |
Vidyanagar Main Road,Near Patel Boarding-360 002
Rajkot
GUJARAT |
0281- 2466990
0281- 2466990
jcamlani@yahoo.com |
| Dr. N. K. Mohanty |
V M Medical College and Safdarjang Hospital, |
Sri Aurobindo Marg,-110 029
New Delhi
DELHI |
011 - 26190954
011 ? 26190954
nayankm@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| IEC (DrAmlani), Ahmedabad |
Approved |
| IEC (DrGandhi), Ahmedabad |
Approved |
| IEC (DrKapil), Ahmedabad |
Approved |
| IEC (DrKetan), Ahmedabad |
Approved |
| IEC (DrMoorthy), Ahmedabad |
Approved |
| IEC (DrRasesh), Ahmedabad |
Approved |
| IEC (DrShukla), Ahmedabad |
Approved |
| IEC, Cancer hospital & research institute, Gwalior |
Approved |
| IEC, Choithram Hospital & Research Centre |
Approved |
| IEC, Christian Medical College |
Approved |
| IEC, Indira Gandhi Hospital, Shimla |
Approved |
| IEC, Muljibhai Patel Urological Hospital |
Approved |
| IEC, PGIMER & Dr R M L Hospital, New delhi |
Approved |
| IEC, Post Graduate Institute of Medical Education and Research, Chandigadh |
Approved |
| IEC, post graduate medical education and research and SSKM hospital, kolkata |
Approved |
| IEC, S. P. Medical College & A. G. of Hospitals |
Approved |
| IEC, V M Medical College and Safdarjang Hospital, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
BCG refractory Superficial transitional cell carcinoma., (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Mycobacterium w |
Dose - 0.2 ml /0.1ml, Route - Intradermal 0.1 ml over each deltoid on first visit thereafter 0.1ml on any one deltoid on all the successive visits., Duration - Every 14 days x 3 months and then monthly for 6 months thereafter once in two months for 6 months. |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed Consent obtained & signed:
o Ability to understand and the willingness to sign a written informed consent document.
2. Disease characteristics:
Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ,
multiple unresected T1 and Ta high grade.
Performance status-ECOG 0-2
Life expectancy- -At least 24 weeks
Haemopoetic values -Absolute neutrophil count greater than or equal to 1,500/mm3, Platelet count greater than or equal to 100,000/mm3, Hemoglobin greater than or equal to 9.0 g/dL
|
|
| ExclusionCriteria |
| Details |
Patients have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
Pregnant or nursing women
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, diabetes mellitus unstable angina pectoris, hepatic dysfunctions or with evidence of Cirrhosis cardiac arrythemia, or psychiatric illness/social situations that would limit compliance with study requirements
History of hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs or any study reagents
History of splenectomy
Clinically significant active infection
Patients who are immuno-compromised
Patients with eczema
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
-Response Rate:
-Time to Tumor Progression
-Safety
|
Response Rate: Tumor will be evaluated after every 3 months by doing sonography, cystoscopy and cytology to find out response rate. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
-Time to tumor progression
-Safety |
Time to Tumor Progression: Time to tumor progression will be evaluated every 3 months for 15 months during the study period.
Safety: Safety will be evaluated by the various side effects patient comes across while on study drug.
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
28/01/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Single arm Clinical trial of Mw(intradermal) in BCG refractory Superficial transitional cell carcinoma to study the efficacy and safety of Mw. Subjects with BCG refractory STCC meeting inclusion and exclusion criteria after transurethral resection will be screened and enrolled in this study. Eligible subjects will receive Mw intradermally every 14 days x 3 months and then monthly for 6 months thereafter once in two months for 6 months. Patients will be evaluated for response every 3 months by cystoscopy, cytology and bladder biopsy up to 15 months during study period.
Expected time to finish the enrollment is 12 months & expected study duration is 27 months. Duration of subject participation is 15 months. Patients demonstrating a complete response will undergo close surveillance by cystoscopy, cytology and bladder biopsy. The surveillance schedule includes urine cytology, serial cystoscopies and biopsy of any suspicious mucosal lesions at every 3 months. Patients who will not respond will be recommended to undergo a radical cystectomy.
Pretreatment studies will include an ECG and chest-x ray. Physical examination and assessment of toxicity will be performed before administration and during therapy. A CBC will be obtained at the end of the 12 week. A biochemistry panel examining liver enzymes and renal function will be performed at the beginning of study and during study. An evaluation under anesthesia with bladder biopsies will be performed at 12 weeks of therapy to assess for response.
Intradermal treatment will be discontinued if the patient develops neutropenic fever (absolute granulocyte count < 1,000 cells/mL3 at the time of a documented temperature of 38 °C), documented bacteremia in the presence of neutropenia, grade 3 or 4 neutropenia or thrombocytopenia, bilirubin more than 1.5, or transaminases more than 3x normal. Treatment will be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described above may be administered with the intent to treat the patient's malignancy.
|