Superficial Bladder CancerPhase 1IPOPNCT00782587
Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer
A Phase 1 study testing Chemophase in people with Superficial Bladder Cancer, run by Halozyme Therapeutics at 5 sites in United States.
Trial summary
The purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- Chemophase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2008to Aug 2009
- 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
- Patient with histologically confirmed or suspected (based on cystoscopy) initial presentation or recurrence of Stage Ta, T1, or Tis transitional cell bladder cancer of any histological grade requiring TURBT.
- Patient believed to be a candidate for immediate post-operative chemotherapy regardless of the need for additional intravesical therapy.
- ECOG performance status of Grade 0 or 1.
- Age ≥ 18 years.
- A negative urine or serum pregnancy test (if female of child-bearing potential) within 14 days prior to Day 1/Week 1.
- Acceptable liver function within 14 days prior to Day 1/Week 1 defined as:
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- Total bilirubin ≤ 1.5 times upper limit of normal (ULN), and
- AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 times ULN.
- Acceptable renal function within 14 days prior to Day 1/Week 1 defined as serum creatinine ≤ 1.5 x ULN.
- Acceptable hematologic status within 14 days prior to Day 1/Week 1 defined as:
- Absolute neutrophil count (ANC) ≥ 1,500/dL,
- Platelet count ≥ 100,000/dL, and
- Hemoglobin ≥ 10.0 g/dL.
- Urinalysis showing no clinically significant abnormalities, except those attributable to bladder cancer.
- For men and women of child-producing potential, agreement to use an effective contraceptive method during the study from enrollment until 2 weeks after the administration of study drug.
- Signed, written, IRB-approved informed consent.
Who cannot join
- Large resected area (estimated total area > 50 cm²) or suspected deep resection, even in the absence of signs of perforation beyond the muscularis propria or ongoing significant bleeding.
- Known or suspected bladder perforation during TURBT.
- Failure to completely resect all cancerous lesions or suspected presence of muscle-invasive cancer (Stage T2 or higher).
- Previous diagnosis or current presence of bladder fibrosis/contracture, or total bladder capacity estimated at cystoscopy or by other means to be < 150 mL.
- Urinary incontinence or severe irritative voiding symptoms such as urgency, frequency, or nocturia of a severity that would compromise the ability of the patient to retain the study drug intravesical instillation for one hour.
- Bladder cancer recurrence less than 3 months after a previous TURBT.
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- Major surgery, other than TURBT or diagnostic surgery, within 28 days prior to Day 1/Week 1.
- Known active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection.
- Any intravesical therapy within 3 months prior to Week 1/Day 1.
- Systemic therapy including radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to Day 1/Week 1 (two months for nitrosoureas or MMC), unless given as standard treatment for bladder cancer and provided that patient is free of all treatment-related toxicities as of Day 1/Week 1.
- Known infection with HIV.
- Known active infection with hepatitis B or hepatitis C virus.
- Serious disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor (Halozyme).
- History of hypersensitivity or idiosyncratic reaction to, or other contraindication to, MMC.
- Known allergy to bee or vespid venom.
- Known coagulation disorder or bleeding tendency.
- Ongoing treatment with heparin or other anticoagulation therapy, or anticipation of such therapy during the treatment period in this study.
- Unwillingness or inability to comply with procedures required in this protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Advanced Urology Medical Center
Anaheim, California, 92801
Malcolm Randall Veterans Administration
Gainesville, Florida, 32608
Medresearch
La Mesa, California, 91942
Advanced Research Institute, Inc.
New Port Richey, Florida, 34655
BCG Oncology, PC
Phoenix, Arizona, 85032
About this study
Official title: Phase I Safety and Tolerability Study of Immediate Post-Operative Intravesical Instillation of Chemophase® (Recombinant Human Hyaluronidase in Combination With Mitomycin) in Patients With Non-Muscle-Invasive Bladder Cancer
The purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically immediately after TURBT (transurethral resection of bladder tumor).
Read the detailed description
Patients will be screened and enrolled prior to undergoing standard of care TURBT for known or suspected Stage Ta, T1 or Tis bladder cancer of any histological grade requiring TURBT and who are believed to be candidates for IPOP intravesical chemotherapy regardless of the need for further intravesical therapy. Within 6 hours after completion of TURBT, patients will be administered a single IPOP intravesical instillation of Chemophase with a one-hour dwell time. At the end of the one-hour dwell time, the patient will be asked to fully void or, if an intravesical catheter has been left in place, the bladder will be fully drained via the catheter. Patients will return at 1 and 2 weeks post instillation for follow up visits for safety and for a cystoscopy at day 85 (per standard of care). Safety and tolerability will be assessed through physical examinations, vital signs, cystoscopy, hematology (CBC), adverse event reporting, and measurements of plasma levels of MMC.
- Conditions
- Superficial Bladder Cancer
- Being tested
- Chemophase
- Keywords
- Non-Muscle-Invasive Bladder Cancer, Superficial Bladder Cancer, recombinant human hyaluronidase, rHuPH20, Chemophase®, Mitomycin
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemophaseDrug
40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single arm, open label, single dose, intravesical instillation of Chemophase (combination of rHuPH20 and mitomycin) for appropriate superficial bladder cancer patients within 6 hours of TURBT. Receives: Drug: Chemophase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of immediate post-operative instillation of Chemophase.
Measured: Day 1 instillation, and weeks 1, 2, and 12
Secondary outcomes (1)
Assess plasma levels of mitomycin (MMC) after IPOP intravesical instillation.
Measured: Hours 1, 2 and 3 post-instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Donald Lamm, M.D., Principal investigator, BCG Oncology, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782587
- Sponsor's protocol ID
- HZ2-08-01
- Acronym
- IPOP
- Status last verified
- Feb 2010
- First submitted
- 29 Oct 2008
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Tolerability Study of Immediate Post-Operative Intravesical Instillation of Chemophase® (Recombinant Human Hyaluronidase in Combination With Mitomycin) in Patients With Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT00782587
- Acronym / sponsor ID
- IPOP / HZ2-08-01
- Conditions
- Superficial Bladder Cancer
- Keywords
- Non-Muscle-Invasive Bladder Cancer, Superficial Bladder Cancer, recombinant human hyaluronidase, rHuPH20, Chemophase®, Mitomycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 31 Oct 2008 (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 purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically immediately after TURBT (transurethral resection of bladder tumor).
Detailed description
Patients will be screened and enrolled prior to undergoing standard of care TURBT for known or suspected Stage Ta, T1 or Tis bladder cancer of any histological grade requiring TURBT and who are believed to be candidates for IPOP intravesical chemotherapy regardless of the need for further intravesical therapy. Within 6 hours after completion of TURBT, patients will be administered a single IPOP intravesical instillation of Chemophase with a one-hour dwell time. At the end of the one-hour dwell time, the patient will be asked to fully void or, if an intravesical catheter has been left in place, the bladder will be fully drained via the catheter. Patients will return at 1 and 2 weeks post instillation for follow up visits for safety and for a cystoscopy at day 85 (per standard of care). Safety and tolerability will be assessed through physical examinations, vital signs, cystoscopy, hematology (CBC), adverse event reporting, and measurements of plasma levels of MMC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ChemophaseSingle arm, open label, single dose, intravesical instillation of Chemophase (combination of rHuPH20 and mitomycin) for appropriate superficial bladder cancer patients within 6 hours of TURBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient with histologically confirmed or suspected (based on cystoscopy) initial presentation or recurrence of Stage Ta, T1, or Tis transitional cell bladder cancer of any histological grade requiring TURBT.
- Patient believed to be a candidate for immediate post-operative chemotherapy regardless of the need for additional intravesical therapy.
- ECOG performance status of Grade 0 or 1.
- Age ≥ 18 years.
- A negative urine or serum pregnancy test (if female of child-bearing potential) within 14 days prior to Day 1/Week 1.
Key exclusion criteria (18 listed)
- Large resected area (estimated total area > 50 cm²) or suspected deep resection, even in the absence of signs of perforation beyond the muscularis propria or ongoing significant bleeding.
- Known or suspected bladder perforation during TURBT.
- Failure to completely resect all cancerous lesions or suspected presence of muscle-invasive cancer (Stage T2 or higher).
- Previous diagnosis or current presence of bladder fibrosis/contracture, or total bladder capacity estimated at cystoscopy or by other means to be < 150 mL.
- Urinary incontinence or severe irritative voiding symptoms such as urgency, frequency, or nocturia of a severity that would compromise the ability of the patient to retain the study drug intravesical instillation for one hour.
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 |
|---|---|---|
| Chemophase40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled | Drug | Arm 1 |
Primary outcome
Safety and Tolerability of immediate post-operative instillation of Chemophase.
Time frame: Day 1 instillation, and weeks 1, 2, and 12
1 secondary outcome
Assess plasma levels of mitomycin (MMC) after IPOP intravesical instillation.
Time frame: Hours 1, 2 and 3 post-instillation
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 8 Feb 2010.
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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.
Donald Lamm, M.D. principal investigator
BCG Oncology, PC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chemophase in people with Superficial Bladder Cancer, run by Halozyme Therapeutics at 5 sites 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 16 inclusion and 18 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 and Tolerability of immediate post-operative instillation of Chemophase. (time frame: Day 1 instillation, and weeks 1, 2, and 12). 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 8 Feb 2010.