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Study 6 of 9 for search of: | "Cadila Pharnmaceuticals" [Exact] |
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Sponsored by: |
Cadila Pharnmaceuticals |
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Information provided by: | Cadila Pharnmaceuticals |
ClinicalTrials.gov Identifier: | NCT00694798 |
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 | Intervention | Phase |
---|---|---|
Superficial Transitional Cell Carcinoma |
Biological: Mycobacterium w |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Mw: Experimental
Mycobacterium w
|
Biological: Mycobacterium w
Immunomodulator
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Informed Consent obtained & signed:
Ability to understand and the willingness to sign a written informed consent document.
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. .
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
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:
Contact: Bhaswat S Chakraborty, PhD. | 91-2714-221481 ext 170 | drb.chakraborty@cadilapharma.co.in |
India, Gujrat | |
Muljibhai Patel Urological Hospital | Not yet recruiting |
Nadiad, Gujrat, India | |
Contact: Mahesh Desai, MD mrdesai@mpuh.org | |
Principal Investigator: Mahesh Desai, MD | |
India, Madhya Pradesh | |
Choithram Hospital and Research Centre | Recruiting |
Indore, Madhya Pradesh, India, 452014 | |
Contact: Sushil Bhatia, MD drsushilbhatia@rediffmail.com | |
Principal Investigator: Sushil Bhatia, MD | |
India, Rajasthan | |
Acharya Tulsi Regional Cancer Treatment & Research Institute | Recruiting |
Bikaner, Rajasthan, India | |
Contact: Amil Lal Bhat, MD amilalbhat@rediffmail.com | |
Principal Investigator: Amil Lal Bhat, MD |
Principal Investigator: | Mahesh Desai, MD | Muljibhai Patel Urological Hospital |
Principal Investigator: | Amil Lal Bhat, MD | S P Medical College & AG of Hospital |
Principal Investigator: | Sushil Bhatia, MD | Choithram Hospital and Research Centre |
Responsible Party: | Cadila Pharmaceuticals Ltd. ( Dr. Bhaswat Chakraborty, Vice President-Clinical Research Organization ) |
Study ID Numbers: | CR-80/8230 |
Study First Received: | June 3, 2008 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00694798 |
Health Authority: | India: Drugs Controller General of India; United States: Food and Drug Administration |
STCC Superficial Transitional Cell Carcinoma- BCG refractor |
Urinary Bladder Neoplasms Mycobacterium Infections Carcinoma, Transitional Cell Transitional cell carcinoma |
Bladder neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type |