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Bladder CancerPhase 1/2NCT00318643

Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer

A Phase 1/2 study testing Mitomycin C and Chemophase in people with Bladder Cancer, run by Halozyme Therapeutics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). 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?
Mitomycin C and Chemophase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
5 sitesUnited States
Study dates
30 Mar 2006to 11 Aug 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants with initial presentation or recurrence of Stage Ta, T1 or Tis, any grade, bladder cancer after transurethral resection of bladder tumor (TURBT).
  • TURBT within 42 days prior to Day 1/Week 1
  • Karnofsky Performance Status greater than or equal to 80%
  • Life expectancy at least 3 years
  • 18 years or older
  • A negative pregnancy test (if female of child-bearing potential)
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  • Acceptable liver function within 7 days defined as: bilirubin less than or equal to 1.5 times upper limit of normal, and aspartate aminotransferase (AST) Glutamic-oxalacetic transaminase (SGOT), alanine aminotransferase (ALT), glutamic-pyruvic transaminase (SGPT), and alkaline phosphatase <= 2.5 times upper limit of normal
  • Acceptable renal function within 7 days defined as: serum creatinine less than or equal to 1.5 times upper limit of normal, or calculated creatinine clearance greater than or equal to 40 milliliter (mL)/minute/1.73 meter^2
  • Acceptable hematologic status within 7 days defined as: absolute neutrophil count (ANC) greater than or equal to 2,500 cells/millimeter^3, platelet count greater than or equal to 150,000/millileter^3, and hemoglobin greater than or equal to 10.0 grams/deciliter.
  • 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 treatment period of the study.
  • Signed, written Institutional Review Board (IRB)-approved informed consent

Who cannot join

  • History or previous diagnosis of bladder fibrosis
  • Total bladder capacity estimated at cystoscopy to be less than 150 mL
  • Urinary incontinence of a severity that would compromise the ability of the participant to retain the study drug intravesical instillation for two hours.
  • Severe irritative voiding symptoms such as urgency, frequency, or nocturia
  • Known other malignant disease except squamous or basal cell skin cancer unless the malignancy has been in complete remission off therapy for at least 5 years.
  • Major surgery, other than TURBT and diagnostic surgery, within 28 days prior to Day 1/Week 1.
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  • Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection.
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to Day 1/Week 1 on study (two months for nitrosureas 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 human immunodeficiency virus (HIV)
  • Known active infection with hepatitis B or hepatitis C
  • 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 a hypersensitivity or idiosyncratic reaction to, or other contraindication to, mitomycin.
  • Known allergy to bee or vespid venom
  • Known coagulation disorder or bleeding tendency
  • Treatment with heparin or anticipation of heparin treatment 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

  • Malcolm Randall Veterans Administration Urology Section (112-C)

    Gainesville, Florida, 32608

  • MedResearch

    La Mesa, California, 91942

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • BCG Oncology

    Phoenix, Arizona, 85032

  • James A. Haley Veterans Hospital

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1-2a, Multicenter, Open-Label, Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of Recombinant Human Hyaluronidase (Chemophase®) in Combination With Mitomycin in Patients With Non-Muscular-Invasive Bladder Cancer

The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase is being specifically developed for use with other anticancer drug to increase the local penetration of the anticancer drug for the treatment of superficial bladder cancer. In this study, Chemophase will be given in combination with mitomycin C directly into the bladder. Mitomycin C is an anti-tumor drug that is commonly used to treat superficial bladder cancer. It is envisioned that Chemophase with mitomycin C may potentially increase the local penetration of mitomycin C into remaining cancer cells following surgery to treat superficial bladder cancer.

Read the detailed description

The primary objectives of this study are to:

  1. determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin (mitomycin C, MMC) administered as weekly intravesical instillations for five weeks, and
  2. establish the dose of Chemophase with MMC recommended for future studies.

The secondary objectives of this study are to:

  1. assess the pharmacokinetics of intravesical administration of MMC alone and in combination with intravesical administration of Chemophase,
  2. for those participants treated at the MTD, assess the safety and tolerability of intravesical administration of MMC with Chemophase over up to 7 additional maintenance treatments every 3 months following the initial six weekly instillations, and
  3. observe participants for any preliminary evidence of anti-tumor activity of MMC and Chemophase when combined.

Study participants will receive six weekly study treatments administered intravesically (at Weeks 1 through 6) followed by post-treatment evaluations, at Weeks 8 and 12. The 12 participants treated at MTD will continue to receive combination therapy every three months until the end of Year 2 or until the time of documented tumor recurrence, whichever occurs first. For other participants, long-term follow-up after Week 12 will consist of disease monitoring of participants by telephone and will be performed every three months beginning three months after last study treatment for two years and then every six months thereafter, until bladder tumor recurrence.

Conditions
Bladder Cancer
Being tested
Mitomycin C, Chemophase
Keywords
Non-invasive bladder cancer, Chemophase, Intravesical administration, Superficial Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitomycin CDrug

    intravesical administration

  • ChemophaseDrug

    intravesical administration

Study groups in NCT00318643
Study groupRoleWhat they receive
Cohort 1: MMC plus Chemophase 20,000 UExperimentalParticipants will receive 40 milligrams (mg) MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Receives: Drug: Mitomycin C; Drug: Chemophase
Cohort 2: MMC plus Chemophase 60,000 UExperimentalParticipants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Receives: Drug: Mitomycin C; Drug: Chemophase
Cohort 3: MMC plus Chemophase 200,000 UExperimentalParticipants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Receives: Drug: Mitomycin C; Drug: Chemophase
Cohort 4: MMC plus Chemophase 400,000 UExperimentalParticipants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Receives: Drug: Mitomycin C; Drug: Chemophase
Cohort 5: MMC plus Chemophase 800,000 UExperimentalParticipants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Receives: Drug: Mitomycin C; Drug: Chemophase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Chemophase in Combination With MMC

    The MTD was defined as the maximum dose level at which no more than two of six participants experienced dose-limiting toxicities (DLT). DLT was defined as any of the following:

    • Plasma MMC concentration greater than or equal to (>=) 100 nanograms (ng)/milliliter (mL)
    • Adverse event (AE) with a Common Toxicity Criteria (CTC) grade greater than or equal to 3
    • New, treatment-emergent diagnosis of bladder fibrosis.

    Measured: 5 weeks (Week 2 to Week 6)

  2. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLT was defined as any of the following:

    • Plasma MMC concentration >= 100 ng/mL
    • AE with a CTC grade greater than or equal to 3
    • New, treatment-emergent diagnosis of bladder fibrosis.

    Measured: 5 weeks (Week 2 to Week 6)

  3. Recommended Dose of Chemophase With MMC For Future Studies

    Measured: 5 weeks (Week 2 to Week 6)

Secondary outcomes (3)

  1. Number of Participants With a Quantifiable MMC Plasma Concentration Value

    A quantifiable MMC plasma concentration value was a value that was not below the quantifiable limit (BQL) of <10.0 nanogram/milliliter (ng/mL).

    Measured: 0 (predose), 1, 2, and 3 hours postdose at Weeks 1, 2, 5, and 6

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    TEAEs were defined as any AE that occurred after the first administration of the study drug and until the end of the study. AEs were defined as any untoward medical occurrence in a participant administered study drug and that did not necessarily have a causal relationship with the study drug. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.

    Measured: Baseline up to 2 years

  3. Number of Participants Who Remained Tumor Free at the End of the Study

    Measured: Baseline up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2006 (estimated)
  2. Study start30 Mar 2006
  3. Primary completion11 Aug 2009
  4. Study completion11 Aug 2009

Resources

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 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318643
Sponsor's protocol ID
HZ2-05-01
Status last verified
Sep 2021
First submitted
25 Apr 2006
Last updated
29 Oct 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mitomycin C and Chemophase in people with 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 12 inclusion and 16 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 29 Oct 2021. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) of Chemophase in Combination With MMC (time frame: 5 weeks (Week 2 to Week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00318643.

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 29 Oct 2021.

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