Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments chemophase, mitomycin c
Phase phase 1/phase 2
Sponsor Halozyme Therapeutics
Start date March 2006
Trial size 27 participants
Trial identifier NCT00318643, HZ2-05-01

Summary

The purpose of this study is to explore other treatments for patients with superficial bladder cancer. The investigational medication to be studied is an enzyme called hyaluronidase, and it is a human recombinant form of the enzyme. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but it may be used in studies such as this one. The drug company name for this medication is Chemophase. Chemophase will be given in combination with mitomycin C. Mitomycin C will be given alone one time and then both drugs will be given together weekly for 5 weeks. Mitomycin C is an anti-tumor drug that is commonly used to treat superficial bladder cancer. Treatments are administered directly into the bladder. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin C (MMC) administered weekly into the bladder for 5 weeks
time frame:
Establish the dose of Chemophase with MMC recommended for future studies
time frame:

Secondary Outcomes

Measure
Pharmacokinetics (PKs) of MMC along and in combination with Chemophase
time frame:
Assess safety and tolerability of MMC with Chemophase over five instillations
time frame:
For patients treated at the MTD, assess safety and tolerability of MMC with Chemophase over up to 7 additional treatments every 3 months following the initial 6 weekly treatments
time frame:
Observe patients for any preliminary evidence of anti-tumor activity of MMC and Chemophase when combined
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients 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) - Acceptable liver function within 7 days defined as: bilirubin less than or equal to 1.5 times upper limit of normal, and AST (SGOT), ALT (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 mL/min/1.73 m2 - Acceptable hematologic status within 7 days defined as: absolute neutrophil count (ANC) greater than or equal to 2,500 cells/mm3, platelet count greater than or equal to 150,000/mm3, and hemoglobin greater than or equal to 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 treatment period of the study. - Signed, written Institutional Review Board (IRB)-approved informed consent Exclusion Criteria: - 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 patient 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. - Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection. - Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one (1) month prior to Day 1/Week 1 on study (two [2] 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.

Additional Information

Official title A Phase I-IIa, 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
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 patients 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 patients for any preliminary evidence of anti-tumor activity of MMC and Chemophase when combined. Study patients will receive six (6) weekly study treatments (at Weeks 1 through 6) followed by post-treatment evaluations, at Weeks 8 and 12. The 12 patients 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 patients, long-term follow-up after Week 12 will consist of disease monitoring of patients by telephone and will be performed every three (3) months beginning three months after last study treatment for two years and then every six (6) months thereafter, until bladder tumor recurrence. The following therapies are prohibited from the time of enrollment through Week 12 of the study: - Treatment with heparin - Any intravesical therapy except for MMC and Chemophase - Any potentially myelosuppressive therapy For the MTD patients who are receiving continued study drug treatments after Week 12, the following therapies are prohibited for the duration of study drug treatment: - Any intravesical therapy except for MMC and Chemophase - Any potentially myelosuppressive therapy
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Halozyme Therapeutics.