CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0091 (clinicaltrials.gov NCT No: NCT00406068)
Title:Open-Label, Multi-Center Study of the Efficacy and Safety of MCC (Mycobacterial Cell Wall-DNA Complex) in the Treatment of Patients with non-muscle invasive (Superficial) Bladder Cancer at High Risk of Progression and Who are Refractory to BCG
Principal Investigator:Jay B. Shah
Treatment Agent:MCC (Mycobacterial cell wall-DNA complex)
Study Status:Terminated
Study Description:The goal of this clinical research study is to study the effect of
mycobacterial cell wall-DNA complex (MCC) on bladder cancer in patients who
have not responded to BCG treatment (in other words, you are "refractory" to
BCG). The safety of the drug will also be studied.

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Disease Group:Bladder
Phase of Study:Phase III
Treatment Agents:MCC (Mycobacterial cell wall-DNA complex)
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Patient may be admitted for 23 hour observation after cystoscopy and biopsy at
3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months
Supported By:Endo Pharmaceuticals Inc
Return Visit:Weekly for 6 weeks, and possible 6 additional weekly instillations.
Evaluations every 3 months with 3 weekly instillation visits. Final
evaluations variable. Early enrollees every 6 months up to 60,
Later enrollees will have fewer evaluations.
Home Care:N/A


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Physician Name:Jay B. Shah
Dept:Urology
For Clinical Trial Enrollment:713-792-3250
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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