Clinical trial NCT00694798: Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: STCC
Superficial Transitional Cell Carcinoma- BCG refractor
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.


Eligibility criteria: Inclusion Criteria:

1. Informed Consent obtained \& signed:

   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.

   BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .
3. Patient Characteristics:

Age: 18 completed years and above Performance status: ECOG 0-2 Life expectancy: At least 24 weeks Hematopoietic:Hemoglobin ≥ 9.0 g/dL

Co-morbidity

* 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.

Note: The effects of Investigational product on the developing human fetus 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.
* Intractable urinary tract infection.
* 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 arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
* Previous splenectomy
* Clinically significant active infection
* Patients with uncontrolled diabetes mellitus.

Primary outcomes:
measure: Response Rate
timeFrame: 15 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Aarogyam Speciality Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Gandhi Urocare
state: Gujarat
city: Ahmedabad
country: India
facility: Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre
state: Gujarat
city: Rajkot
country: India
facility: Urocare Hospital
state: Gujarat
city: Surat
country: India
facility: Excel Hospital, Advanced Laproscopy and Urology Centre
state: Gujarat
city: Vadodara
country: India
facility: Desai Urological & Maternity 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: 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: Ludhiana
country: India
facility: Christian Medical College
state: Punjab
city: Bikaner
country: India
facility: S.P. Medical College & 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: S P Medical College & AG of Hospital
name: Amillal Bhat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Choithram Hospital and Research Centre
name: Sushil Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College, Vellore, India
name: Kim Mammen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siddhi Vinayak Hospital
name: Ketan Rajyaguru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gandhi Urocare
name: Gaurang Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Excel Hospital
name: Kapil Thakkar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital & Research Institute
name: B. R. Shrivastav, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IPGMER, S.S.K.M. Hospital
name: Anup Kundu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urocare Hospital
name: Jitendra Amlani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desai Urological and Maternity Hospital
name: Rasesh Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: V. M. Medical College and Safdarjang hospital
name: N. K. Mohanty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Shrawan K. Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam Speciality Hospital
name: Ketan Shukla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lourdes hospital
name: Krishna Moorhty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Ram Manohar Lohia Hospital and PGIMER
name: Rajeev Sood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indira Gandhi Medical College, Shimla
name: Purshottam K. Puri, MD
role: PRINCIPAL_INVESTIGATOR
References: