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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2009/091/000664
Date of registration:	25-09-2009
Prospective Registration:	No
Primary sponsor:	CADILA PHARMACEUTICALS LTD
Public title:	Study of Mycobacterium w in BCG refractory Superficial Transitional Cell Carcinoma of Bladder
Scientific title:	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
Date of first enrolment:	28-01-2009
Target sample size:	22
Recruitment status:	Completed
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=853
Study type:	Interventional
Study design:	Single Arm Trial Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
Phase:	Phase 1

Countries of recruitment
India

Contacts

Name:	Dr Deepak Sawhney
Address:	1389, Trasad Road, Dholka 387810 Ahmadabad, GUJARAT India
Telephone:	02714-221481
Email:	deepak.sawhney@cadilapharma.co.in
Affiliation:	Cadila Pharmaceuticals Ltd

Name:	Dr Deepak Sawhney
Address:	1389, Trasad Road, Dholka 387810 Ahmadabad, GUJARAT India
Telephone:	02714-221481
Email:	deepak.sawhney@cadilapharma.co.in
Affiliation:	Cadila Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- BCG refractory Superficial transitional cell carcinoma. Health Condition 2: C679- Malignant neoplasm of bladder, unspecified

Intervention(s)

Intervention1: 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.
Control Intervention1: NIL: NIL

Primary Outcome(s)

-Response Rate:

-Time to Tumor Progression

-Safety

Timepoint: Response Rate: Tumor will be evaluated after every 3 months by doing sonography, cystoscopy and cytology to find out response rate.

Secondary Outcome(s)

-Time to tumor progression

-SafetyTimepoint: 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.

Secondary ID(s)

CR-80/8230

NCT00694798

Source(s) of Monetary Support

CADILA PHARMACEUTICALS LTD. 1389, Trasad Road, Dholka, Ahmedabad- 387810

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 17/09/2008
Contact:

IEC, S. P. Medical College & A. G. of Hospitals

Status: Approved
Approval date: 31/10/2008
Contact:

IEC, Muljibhai Patel Urological Hospital

Status: Approved
Approval date: 15/12/2008
Contact:

IEC, Choithram Hospital & Research Centre

Status: Approved
Approval date: 03/02/2009
Contact:

IEC, Christian Medical College