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STCC: Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder

Sponsor
Cadila Pharnmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00694798
Collaborator
(none)
22
Enrollment
17
Locations
1
Arm
33
Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Mycobacterium w
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mw

All enrolled patients to receive Mycobacterium w

Biological: Mycobacterium w
Immunomodulator

Outcome Measures

Primary Outcome Measures

  1. Response Rate [15 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Informed Consent obtained & signed:

Ability to understand and the willingness to sign a written informed consent document.

  1. 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. .

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarogyam Speciality Hospital Ahmedabad Gujarat India
2 Gandhi Urocare Ahmedabad Gujarat India
3 Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre Ahmedabad Gujarat India
4 Urocare Hospital Rajkot Gujarat India
5 Excel Hospital, Advanced Laproscopy and Urology Centre Surat Gujarat India
6 Desai Urological & Maternity Hospital Vadodara Gujarat India
7 Muljibhai Patel Urological Hospital Nadiad Gujrat India
8 Indira Gandhi Medical College Shimla Himachal Pradesh India
9 Lourdes Hospital Kochi Kerala India
10 Choithram Hospital and Research Centre Indore Madhya Pradesh India 452014
11 Cancer Hospital and Research Institute Gwalior Madya Pradesh India
12 Christian Medical College Ludhiana Punjab India 141008
13 S.P. Medical College & A. G. of Hospitals Bikaner Rajasthan India
14 IPGMER, S.S.K.M. Hospital Kolkata West Bengal India
15 Post Graduate Institute of Medical Education and Research Chandigarh India
16 Dr. Ram Manohar Lohia Hospital & PGIMER New Delhi India
17 V. M. Medical College & Safdarjang Hospital New Delhi India

Sponsors and Collaborators

  • Cadila Pharnmaceuticals

Investigators

  • Principal Investigator: Mahesh Desai, MD, Muljibhai Patel Urological Hospital
  • Principal Investigator: Amillal Bhat, MD, S P Medical College & AG of Hospital
  • Principal Investigator: Sushil Bhatia, MD, Choithram Hospital and Research Centre
  • Principal Investigator: Kim Mammen, MD, Christian Medical College, Vellore, India
  • Principal Investigator: Ketan Rajyaguru, MD, Siddhi Vinayak Hospital
  • Principal Investigator: Gaurang Gandhi, MD, Gandhi Urocare
  • Principal Investigator: Kapil Thakkar, MD, Excel Hospital
  • Principal Investigator: B. R. Shrivastav, MD, Cancer Hospital & Research Institute
  • Principal Investigator: Anup Kundu, MD, IPGMER, S.S.K.M. Hospital
  • Principal Investigator: Jitendra Amlani, MD, Urocare Hospital
  • Principal Investigator: Rasesh Desai, MD, Desai Urological and Maternity Hospital
  • Principal Investigator: N. K. Mohanty, MD, V. M. Medical College and Safdarjang hospital
  • Principal Investigator: Shrawan K. Singh, MD, Post Graduate Institute of Medical Education and Research
  • Principal Investigator: Ketan Shukla, MD, Aarogyam Speciality Hospital
  • Principal Investigator: Krishna Moorhty, MD, Lourdes hospital
  • Principal Investigator: Rajeev Sood, MD, Dr. Ram Manohar Lohia Hospital and PGIMER
  • Principal Investigator: Purshottam K. Puri, MD, Indira Gandhi Medical College, Shimla

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00694798
Other Study ID Numbers:
  • CR-80/8230
First Posted:
Jun 11, 2008
Last Update Posted:
May 3, 2012
Last Verified:
May 1, 2012
Keywords provided by Cadila Pharnmaceuticals
STCC
Superficial Transitional Cell Carcinoma- BCG refractor
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell

Study Results

No Results Posted as of May 3, 2012