Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer

NCT00782587 | Completed Phase 1

• 1 other identifier: HZ2-08-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief 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 immediately after TURBT (transurethral resection of bladder tumor).

Conditions

Superficial Bladder Cancer

Keywords

Non-Muscle-Invasive Bladder Cancer; Superficial Bladder Cancer; recombinant human hyaluronidase; rHuPH20; Chemophase®; Mitomycin

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of immediate post-operative instillation of Chemophase.

  Day 1 instillation, and weeks 1, 2, and 12

Secondary Outcomes (1)

• Assess plasma levels of mitomycin (MMC) after IPOP intravesical instillation.

  Hours 1, 2 and 3 post-instillation

Study Arms (1)

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.

Drug: Chemophase

Interventions

Chemophase DRUG

40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Halozyme Therapeutics: lead

Study Sites (5)

BCG Oncology, PC

Phoenix, Arizona, 85032, United States

Location

Advanced Urology Medical Center

Anaheim, California, 92801, United States

Location

Medresearch

La Mesa, California, 91942, United States

Location

Malcolm Randall Veterans Administration

Gainesville, Florida, 32608, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34655, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Donald Lamm, M.D.

  BCG Oncology, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 8, 2010

Record last verified: 2010-02

Locations

US (5)