Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01162785
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2010-07-13
Brief Title:
1B Intravesical Administration of SCH 721015 Ad-IFNa in Admixture With SCH 209702 Syn3 for The Treatment of BCG Refractory Superficial Bladder Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 bodys 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 BO 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 12 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
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 bodys 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 BO 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 12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50CA091846 | NIH | None | None |
| NCI-2010-01769 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP50CA091846 |