MDACC Study Summary 2007-0091 (Archived)

Study Summary
No. 2007-0091:.......Bladder......Jay B. Shah......Urology

Study Summary Title



Study Summary Number:	2007-0091

Study 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

Physician

New Patient Referral



Name:	Jay B. Shah	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Bladder	Supported By:	Endo Pharmaceuticals Inc

Phase of Study:	Phase III	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.

Treatment Agents:	MCC (Mycobacterial cell wall-DNA complex)	Home Care:	N/A

Treatment Loc:	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


Description/ Intervention:	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.

Study Objectives / Outcomes

The objective of this study is to determine the efficacy and safety of intravesical MCC (Mycobacterial Cell wall-DNA complex) in patients with non-muscle invasive urothelial carcinoma (papillary tumors and/or CIS) of the urinary bladder at high risk of progression who are refractory to therapy with BCG. The primary efficacy objective will be to show a true one-year disease-free survival rate of not less than 40%. In addition, the two-year disease-free survival, the disease-free rate at 3 and 6 months, the duration of disease-free survival in all patients, the time to progression and the overall survival (time to death from any cause) in all patients will be evaluated as secondary efficacy endpoints.

The primary safety objective will be to evaluate MCC with respect to the frequency at which treatment is delayed or stopped due to drug-related adverse events. The nature, severity and frequency of all adverse events will also be evaluated as secondary safety endpoints.

Study Status Information



Study Activation / Registration Date:	05/30/2007

IRB Review and Approval Date:	04/10/2007

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	105

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Males and females, 18 years of age and over;

2) If applicable, have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;

3) Patients refractory to BCG therapy;

4) Patients with one of the following diagnoses according to the local pathologist: 1) High grade Ta and/or T1 papillary lesion(s); 2) CIS, with or without Ta or T1 papillary tumor(s) of any grade;

5) Available for the whole duration of the study including follow-up (up to 60 months);

6) Life expectancy of > 5 years;

7) Patients with an ECOG performance status grade of 2 or less.

8) Absence of urothelial carcinoma involving the upper urinary tracts or prostatic urethra (confirmed by upper tract radiological imaging) and/or biopsy within 12 months from beginning of study treatment;

9) Able to understand and give written informed consent;

10) In the investigator's judgment the patient is able to participate in the study.

11) TURBT or biopsy specimen used to diagnose T1 stage must include a portion of the underlying muscle to confirm stage.

12) Histologically confirmed diagnosis of high grade disease must be within 56 days prior to beginning of treatment;

Exclusion Criteria:

1) Current or previous history of muscle invasive bladder tumors (>/= T2);

2) Current systemic cancer therapy (cytotoxic/cytostatic or immunotherapy);

3) Current or prior pelvic external beam radiotherapy;

4) Patients with existing urinary tract infection or recurrent severe bacterial cystitis;

5) Clinically significant and unexplained elevations of liver or renal function tests;

6) White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);

7) Severe cardiovascular disease such as myocardial infarction within the past three months, unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or uncontrolled cardiac arrhythmia;

8) Women who are pregnant or lactating. Women of childbearing potential must use an effective contraceptive method such as oral contraceptive pills, diaphragm or condoms;

9) Congenital or acquired immune deficiency;

10) With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);

11) Previous investigational treatment within 3 months from beginning of study treatment;

12) Patients who cannot hold the instillation for one hour;

13) Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);

14) Clinically significant active infections;

15) Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.

16) Current or previous history of lymph node or distant metastases from bladder cancer;

17) Pelvic brachytherapy within 2 years of study entry;

18) Prior treatment with MCC;

Links

Registration Number: NCT00406068
Study Information on Clinical Trials Registry (clinicaltrials.gov)