Bladder CancerPhase 1NCT01162785
1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
A Phase 1 study testing SCH 721015 in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- SCH 721015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
- Patients with recurrent T1 disease who do not wish to have cystectomy.
- 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.
- At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
- Subjects must be 18 years of age or older
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- Life expectancy of at least 3 months
- Adequate performance status (Karnofsky score >/= 70%)
- Adequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) White blood cell count (WBC) >/= 3000/µL. c) Absolute neutrophil count (ANC) >/= 1500/µL. d) Platelet count >/=100,000/µL. e) PT </= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) </= 1.5 x ULN. g) AST </=1.5 x ULN. h) ALT </= 1.5 x ULN. i) Total bilirubin </= 1.5 x ULN. j) Creatinine </=1.5 x ULN.
- 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. intrauterine device (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.
- 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
Who cannot join
- Pregnant or nursing women
- Suspected hypersensitivity to interferon alpha
- Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
- Subjects with organ transplants
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
- b. Central nervous system (CNS) trauma or active seizure disorders requiring medication
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- 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
- d. Poorly controlled diabetes mellitus (HbA1C >10.0%);
- e. Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months.
- f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
- Donation of blood within the preceding 60 days prior to study registration.
- 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.
- History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration
- Untreated bladder infection
- Positive for hepatitis BsAg or HIV Ab or hepatitis C
- Immunosuppressive therapy within the last 3 months
- Subjects who are part of the staff personnel directly involved with this study
- Subjects who are family members of the investigational study staff
- Traumatic catheterization within 1 month
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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 goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.
Read the detailed description
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.
- Conditions
- Bladder Cancer
- Being tested
- SCH 721015
- Keywords
- 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
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 721015Drug
Also called rAd-IFN
Intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume. Administered into bladder through a urinary catheter, 75 mL will be instilled, left in the bladder for 1 hour, plus or minus 10 minutes. During the dwell time, subject will be repositioned from left to right, back and abdomen to maximize bladder surface exposure, approximately every 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| First Dose SCH 721015 | Experimental | Part1: 2 Instillations of intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume Receives: Drug: SCH 721015 |
| Second Dose SCH 721015 | Experimental | Part 2: Subjects who have a complete response to treatment at Week 12 in Part 1 receive second regimen of intravesical administration of SCH 721015 with Syn3 on same Day 1 and Day 4 regimen at same dose level. Receives: Drug: SCH 721015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4
Measured: Daily urine collection for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startApr 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- FKD Therapies Oy of Finland, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Colin P. Dinney, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162785
- Sponsor's protocol ID
- 2009-0938
- Other IDs
- P50CA091846, NCI-2010-01769
- Status last verified
- Nov 2016
- First submitted
- 13 Jul 2010
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT01162785
- Acronym / sponsor ID
- 2009-0938
- Conditions
- Bladder Cancer
- Keywords
- BCG Refractory Superficial Bladder Cancer, SCH 721015, Syn3, novel excipient, interferon -alpha-2b, Intravesical, urine IFNa, transitional cell carcinoma of the bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- FKD Therapies Oy of Finland, National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Dose SCH 721015 | Experimental | Drug: SCH 721015Part1: 2 Instillations of intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume |
| Second Dose SCH 721015 | Experimental | Drug: SCH 721015Part 2: Subjects who have a complete response to treatment at Week 12 in Part 1 receive second regimen of intravesical administration of SCH 721015 with Syn3 on same Day 1 and Day 4 regimen at same dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
- Patients with recurrent T1 disease who do not wish to have cystectomy.
- 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.
- At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
Key exclusion criteria (19 listed)
- Pregnant or nursing women
- Suspected hypersensitivity to interferon alpha
- Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
- Subjects with organ transplants
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCH 721015Also: rAd-IFNIntravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume. Administered into bladder through a urinary catheter, 75 mL will be instilled, left in the bladder for 1 hour, plus or minus 10 minutes. During the dwell time, subject will be repositioned from left to right, back and abdomen to maximize bladder surface exposure, approximately every 15 minutes. | Drug | First Dose SCH 721015, Second Dose SCH 721015 |
Primary outcome
Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4
Time frame: Daily urine collection for 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin P. Dinney, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCH 721015 in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Daily urine collection for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.