Bladder CancerPhase 1NCT00006476
Suramin in Treating Patients With Recurrent Bladder Cancer
A Phase 1 study testing suramin and conventional surgery in people with Bladder Cancer, run by Cancer Research UK at 1 site in United Kingdom.
Trial summary
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer. 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?
- suramin and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2000to Oct 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically proven recurrent superficial bladder cancer
- Intermediate prognosis as defined by the following:
- Recurrent, multiple Ta, T1 carcinoma
- Multiple (1-7) tumors
- Tumors resected previously must be histological grade G1 or G2 OR
- Previously treated superficial bladder cancer requiring followup cystoscopy
- Recurrent disease diagnosed at surgery
- No tumor invasion into muscle or carcinoma in situ
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm3
- Platelet count at least 150,000/mm3
Hepatic:
- No clinically significant hepatic disease
Renal:
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No history of adrenal insufficiency
- No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer
- No history of difficult catheterization
- No confusion or disorientation
- No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- No prior radiotherapy to the bladder
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major thoracic or abdominal surgery
Other:
- Recovered from prior therapy and stable for 4 weeks
- At least 6 weeks since prior intravesicular therapy
- No prior or concurrent investigational drugs
- No concurrent anticoagulants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
About this study
Official title: A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
- Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.
OUTLINE: This is a dose escalation study.
At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity.
Patients are followed at 2-4 weeks.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
- Conditions
- Bladder Cancer
- Being tested
- suramin, conventional surgery
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer
- 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.
suraminDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2000
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Adrian L. Harris, MD, Study chair, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006476
- Sponsor's protocol ID
- CRC-PHASE I/II-PH1/073
- Other IDs
- CDR0000068303, NCI-954
- Status last verified
- Mar 2007
- First submitted
- 6 Nov 2000
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7. doi: 10.1038/sj.bjc.6602650.
PubMed 15928663
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00006476
- Acronym / sponsor ID
- CRC-PHASE I/II-PH1/073
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Oct 2000
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
- Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.
OUTLINE: This is a dose escalation study.
At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity.
Patients are followed at 2-4 weeks.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| suramin | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 26 Jun 2013.
- Results publication: PubMed 15928663Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7. doi: 10.1038/sj.bjc.6602650.
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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.
Adrian L. Harris, MD study chair
Oxford University Hospitals NHS Trust
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 suramin and conventional surgery in people with Bladder Cancer, run by Cancer Research UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Jun 2013. 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 Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006476, which also lists 1 linked publication.
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 26 Jun 2013.