Bladder CancerPhase 1NCT00082719
Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium
A Phase 1 study testing Recombinant Interferon Alfa in people with Bladder Cancer and Urethral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer. PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer, Urethral Cancer
- What is being tested?
- Recombinant Interferon Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson.
- Patients must understand the investigational nature of this study and provide written, informed consent.
Who cannot join
- Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
- Patients with current symptoms suggestive of clinically significant affective disorder.
- Patients taking more than physiologic replacement doses of corticosteroids are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer.
PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium.
Read the detailed description
OBJECTIVES:
- Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy.
- Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.
- Arm II: Patients receive interferon alfa as in arm I at a higher dose.
- Arm III: Patients receive interferon alfa SC once daily.
- Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms, treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
- Conditions
- Bladder Cancer, Urethral Cancer
- Being tested
- Recombinant Interferon Alfa
- Keywords
- stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, localized transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, metastatic transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Interferon AlfaBiological
Also called Interferon Alfa 2b, Intron A
In all arms, treatment begins at pre-operative visit and continues until cystoscopy.
Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Low-dose interferon alfa subcutaneously (SC) twice daily. Receives: Biological: Recombinant Interferon Alfa |
| Arm II | Experimental | Interferon alfa as in arm I at a higher dose. Receives: Biological: Recombinant Interferon Alfa |
| Arm III | Experimental | Interferon alfa SC once daily. Receives: Biological: Recombinant Interferon Alfa |
| Arm IV | Experimental | Interferon alfa as in arm III at a higher dose. Receives: Biological: Recombinant Interferon Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
Data collection continues with treatment in absence of unacceptable toxicity.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study startDec 2003
- Primary completionJan 2015
- Study completionJan 2015
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ashish M. Kamat, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082719
- Sponsor's protocol ID
- ID03-0172
- Other IDs
- P50CA091846, P30CA016672, MDA-ID-030172, CDR0000355831, NCI-2012-02015
- Status last verified
- May 2015
- First submitted
- 14 May 2004
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
- ClinicalTrials.gov ID
- NCT00082719
- Acronym / sponsor ID
- ID03-0172
- Conditions
- Bladder Cancer, Urethral Cancer
- Keywords
- stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, localized transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, metastatic transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 May 2004 (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.
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer.
PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium.
Detailed description
OBJECTIVES:
- Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy.
- Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.
- Arm II: Patients receive interferon alfa as in arm I at a higher dose.
- Arm III: Patients receive interferon alfa SC once daily.
- Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms, treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: Recombinant Interferon AlfaLow-dose interferon alfa subcutaneously (SC) twice daily. |
| Arm II | Experimental | Biological: Recombinant Interferon AlfaInterferon alfa as in arm I at a higher dose. |
| Arm III | Experimental | Biological: Recombinant Interferon AlfaInterferon alfa SC once daily. |
| Arm IV | Experimental | Biological: Recombinant Interferon AlfaInterferon alfa as in arm III at a higher dose. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson.
- Patients must understand the investigational nature of this study and provide written, informed consent.
Key exclusion criteria (3 listed)
- Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
- Patients with current symptoms suggestive of clinically significant affective disorder.
- Patients taking more than physiologic replacement doses of corticosteroids are not eligible.
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 |
|---|---|---|
| Recombinant Interferon AlfaAlso: Interferon Alfa 2b, Intron AIn all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose. | Biological | Arm I, Arm II, Arm III, Arm IV |
Primary outcome
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
Time frame: 2 Years
Data collection continues with treatment in absence of unacceptable toxicity.
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 14 May 2015.
- University of Texas MD Anderson Cancer Center Official 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.
Ashish M. Kamat, MD principal investigator
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 Recombinant Interferon Alfa in people with Bladder Cancer and Urethral 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 2 inclusion and 3 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 14 May 2015. 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?
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon (time frame: 2 Years). 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 14 May 2015.