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Phase 1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Phase 1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer


The Study Drug:

SCH 72105 is designed to cause "gene transfer" by giving a gene called interferon -alpha-2b
into the body. SCH 72105 is made after being processed in the lab with a study drug called
Syn3. This combination of study drugs is also called SCH 721015 with Syn3. Syn3 is
designed to help the body make a protein called interferon -alpha-2b, and this may help the
body's immune system to react against the cancer.

Study Drug Administration:

On Days 1 and 4, SCH 72105 will be given into your bladder over about 1 minute through a
urinary catheter. A urinary catheter is a thin flexible tube placed through the urinary
tube and into the bladder. SCH 72105 will stay in the bladder for about 1 hour. You will
be asked to turn from left to right, back to stomach, every 15 minutes to allow the bladder
surface to be exposed to the drug.

A belladonna and opium (B&O) suppository will be inserted into your rectum about 30 minutes
before the study drug doses. Levsin SL (hyoscyamine sulfate) will be given by mouth about
15 minutes before the study drug doses. These drugs are used to lower the risk of urinary
urgency (a strong need to urinate).

Study Visits:

On Day 1:

- Blood (about 3 teaspoons) will be drawn for routine tests.

- Urine will be collected to test for IFN levels and to check for infection.

- Your vital signs will be measured before and after the study drug dose.

- You will be asked about any side effects and urinary symptoms you may have had and any
drugs you may be taking.

- Your performance status will be recorded.

On Days 2 and 3 and on Days 5-14:

- Urine will be collected for biomarker testing. Biomarkers in your urine may be related
to your reaction to the study drug.

- Your performance status will be recorded.

- You will be asked about any side effects and urinary symptoms you may have had and any
drugs you may be taking.

On Day 4:

- Blood (about 3 teaspoons) will be drawn for routine tests.

- Urine will be collected for biomarker testing and to check for infection.

- Your vital signs will be measured before and after the study drug dose.

- You will be asked about any side effects and urinary symptoms you may have had and any
drugs you may be taking.

- Your performance status will be recorded.

During Days 1-11, you will add about 1/2 cup of bleach to the toilet bowl before every time
you urinate. You will then wait 15 minutes before flushing. You should avoid public
bathrooms on these days. This procedure is required to avoid exposing other people to the
study drug.

One (1) time a week during Weeks 2-11, the study staff will call and ask you about any side
effects and urinary symptoms you may have had and any drugs you may be taking. During these
calls, your performance status will also be recorded.

At Week 12:

- You will have a physical exam.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- Urine will be collected for biomarker testing and to check for infection.

- Your vital signs will be measured.

- You will have an ECG. This ECG will be used as a screening test to help the doctor
decide if you are eligible to take part in Part 2 of the study.

- Your performance status will be recorded.

- You will be asked about any side effects and urinary symptoms you may have had and any
drugs you may be taking.

- You will have a cystoscopy with biopsies to check the status of the disease. All areas
that the doctor thinks might have a tumor will be biopsied. Your bladder will also be
measured during this procedure.

Length of Participation:

You may receive the 2 doses of the study drug as planned, if the doctor thinks it is in your
best interest. You will not be able to receive the second dose of the study drug if the
disease gets worse or intolerable side effects occur.

Part 2 of the Study:

If the disease has completely responded by Week 12 (no sign of cancer), you will be asked to
take part in Part 2 of this study. In Part 2, participants will receive another 2 doses of
the study drug. There is a separate informed consent form that describes Part 2, including
screening tests that will help the doctor decide if you are eligible. You will be asked to
sign the informed consent form if you agree to take part.

The level of effectiveness of SCH72105 treatment will be studied by measurement of IFN
levels in the daily urine collections.

End-of-Study Visit:

You may choose to stop your study participation at any time. If you choose to stop before
the Week 12 visit, you will be asked to return for an end-of-study visit. You will also be
called by the study staff to ask about your health 1 time a year for the next 2 years. The
following tests and procedures will be performed at the end-of-study visit:

- You will have a physical exam.

- You will have an ECG.

- Urine will be collected for routine tests.

Follow-Up:

If you had any signs of bladder cancer at Week 12, the study staff will call you at Months
6, 9, 12, 24, and 36. You will be asked if you have had any serious side effects.

This is an investigational study. SCH 72105 is not FDA approved or commercially available.
It is currently being used for research purposes only.

Up to 9 patients will take part in this study (9 total, for Parts 1 and 2). All will be
enrolled at MD Anderson.


Inclusion Criteria:



1. Subjects must be willing to give written informed consent and be able to adhere to
dose and visit schedules.

2. Histologically proven recurrent urothelial carcinoma of the bladder or prostatic
urethra, Stage Tis, Ta

3. Patients with recurrent T1 disease who do not wish to have cystectomy.

4. Subjects must have failed at least two prior courses of BCG with or without
recombinant interferon alpha administration or be BCG intolerant. This includes
either two six week induction courses of BCG or a 6 week induction course followed by
a 3 week mini-induction course of maintenance BCG.

5. At least 3 months must have passed since last BCG therapy or intravesical treatment
for bladder carcinoma.

6. Subjects must be 18 years of age or older

7. Life expectancy of at least 3 months

8. Adequate performance status (Karnofsky score >/= 70%)

9. Adequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) WBC >/= 3000/µL. c) ANC >/=
1500/µL. d) Platelet count >/=100,000/µL. e) PT g) AST Creatinine
10. Female subjects of childbearing potential (Female subjects who are not surgically
sterilized, not at least 1 year postmenopausal) must agree to use adequate
contraception (e.g. IUD, condom plus spermicide, diaphragm, or cervical cap plus
spermicide) or medical contraception: during the study and for at least 1 month prior
to drug administration and for 4 months after treatment. Females who are not
currently sexually active must agree and consent to use one of the above-mentioned
methods should they become sexually active while participating in the Study.

11. Male subjects who are sexually active must agree to use a condom from the beginning
of treatment and for 1 month after the last dose

Exclusion Criteria:

1. Pregnant or nursing women

2. Suspected hypersensitivity to interferon alpha

3. Participation in another clinical trial or use of any investigational drug within 30
days prior to study entry

4. Subjects with organ transplants

5. Any known preexisting medical condition that could interfere with the subject's
participation in and completion of the study such as:

6. b. CNS trauma or active seizure disorders requiring medication

7. c. Significant cardiovascular dysfunction within the past 6 months including
symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring
hospitalization or emergency room visit within last 3 months

8. d. Poorly controlled diabetes mellitus (HbA1C >10.0%);

9. e. Unstable pulmonary disease requiring hospitalization or emergency room visit
within the last 3 months.

10. f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis,
immune mediated glomerulonephritis).

11. Donation of blood within the preceding 60 days prior to study registration.

12. Any other condition that, in the opinion of the investigator, would make the subject
unsuitable for enrollment or could interfere with the subject participating in and
completing the protocol.

13. History of any clinically significant local or systemic infectious disease within 4
weeks prior to initial treatment administration

14. Untreated bladder infection

15. Positive for hepatitis BsAg or HIV Ab or hepatitis C

16. Immunosuppressive therapy within the last 3 months

17. Subjects who are part of the staff personnel directly involved with this study

18. Subjects who are family members of the investigational study staff

19. Traumatic catheterization within 1 month

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4

Outcome Time Frame:

Daily urine collection for 14 days

Safety Issue:

Yes

Principal Investigator

Colin P. Dinney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0938

NCT ID:

NCT01162785

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Bladder Cancer
  • BCG Refractory Superficial Bladder Cancer
  • SCH 721015
  • Syn3
  • novel excipient
  • interferon -alpha-2b
  • Intravesical
  • urine IFNa
  • transitional cell carcinoma of the bladder
  • superficial non-muscle invasive tumor
  • Urinary Bladder Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030