Clinical trial NCT00694915: Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder
Official title: Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: STCC (Superficial Transitional Cell Carcinoma)
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent.
* Patients with newly diagnosed superficial transitional cell carcinoma with completely resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade 2, T1 Grade 3 \& CIS.

and Ta or T1 disease with an increased risk of recurrence defined as 2 tumors (primary and recurrent or 2 recurrences) within 1 year, 3 or more within the last 6 months and/ or carcinoma in situ on at least one random biopsy.

* 18 years or above
* ECOG of 0-2 range
* life expectancy is at least 24 weeks.
* Absolute neutrophil count≥1,500/c.mm
* platelet count≥100,000//c.mm
* Hemoglobin ≥9.0g/dL

  * No patient who has eczema will be allowed to participate in this study.
  * Patients who are immuno-compromised will not be enrolled.
  * Patients with severe hepatic dysfunctions or with evidence of Cirrhosis will not be enrolled.
  * Patients with uncontrolled diabetes mellitus will not be enrolled in the study
  * No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR

Note: The effects of Investigational product on the developing human fetus is at the recommended therapeutic dose are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

* Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
* No patient who has eczema should be allowed to participate in this study.
* Patients who are immuno-compromised should not be enrolled.
* Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
* Pregnant women or nursing women are excluded from this study because agents used in the study have potential for teratogenic or abortifacient effects. Because there is known potential risk for adverse events in nursing infants secondary to treatment of the mother with investigational agent, breastfeeding should be discontinued if the mother is treated with investigational product.
* 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.
* Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
* Previous splenectomy
* Clinically significant active infection
* Patients with uncontrolled diabetes mellitus.

Primary outcomes:
measure: Recording of any clinical adverse reactions at anytime during the study for assessment of safety
timeFrame: 24 months
measure: Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities
timeFrame: 24 months
measure: Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period
timeFrame: 15
Other outcomes:
Locations:
city: Rajkot
country: India
facility: Urocare Hospital
state: Gujarat
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
state: Gujrat
city: Shimla
country: India
facility: Indira Gandhi Medical College
state: Himachal Pradesh
city: Bangalore
country: India
facility: N.R.R. Hospital
state: Karnataka
city: Manipal
country: India
facility: Kasturba Medical college and Hospital
state: Karnataka
city: Kochi
country: India
facility: Lourdes Hospital
state: Kerala
city: Indore
country: India
facility: Choithram Hospital and Research Centre
state: Madhya Pradesh
city: Gwalior
country: India
facility: Cancer Hospital and Research Institute
state: Madya Pradesh
city: Parel
country: India
facility: Seth G S Medical College & K E M Hospital
state: Mumbai
city: Ludhiana
country: India
facility: Christian Medical College
state: Punjab
city: Bikaner
country: India
facility: P.B.M. Hospital & A.G. of Hospitals
state: Rajasthan
city: Kolkata
country: India
facility: IPGMER, S.S.K.M. Hospital
state: West Bengal
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: New Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital & PGIMER
city: New Delhi
country: India
facility: V M Medical College & Safdarjang Hospital
Study officials:
affiliation: Muljibhai Patel Urological Hospital
name: Mahesh Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: V M Medical College & Safdarjang Hospital
name: N K Mohanty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S P Medical College & AG of Hospitals
name: Amillal Bhat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seth G S Medical College & K E M Hospital
name: Sujata Patwardhan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College, Vellore, India
name: Kim Mammen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Choithram Hospital and Research Centre
name: Sushil Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital and Research Institute
name: B. R. Srivastav, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urocare Hospital
name: Jitendra Amlani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital
name: Anup Kundu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lourdes Hospital
name: H. K. Moorthy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education & Research
name: Shrawan K. Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indira Gandhi Medical College, Shimla
name: Purshottam K. Puri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Ram Manohar Lohia Hospital & PGIMER
name: Rajeev Sood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasturba Medical College & Hospital
name: Padmaraj Hegde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: N.R.R. Hospital
name: Yathish Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: