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COMPLETED Phase 1

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

NCT00318643 · View on ClinicalTrials.gov ↗

Study 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). 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.

Conditions Studied

Interventions

  • DRUG Mitomycin C
  • DRUG Chemophase

Study Locations (5)

Florida

  • Malcolm Randall Veterans Administration Urology Section (112-C) — Gainesville
  • Advanced Research Institute — New Port Richey
  • James A. Haley Veterans Hospital — Tampa

Arizona

  • BCG Oncology — Phoenix

California

  • MedResearch — La Mesa

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2006-03-30
Est. Completion 2009-08-11
Phase Phase 1

Sponsor

Halozyme Therapeutics

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00318643

The ClinicalTrials.gov registry entry for NCT00318643 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions — of which Mitomycin C is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00318643 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00318643 about?

NCT00318643 is a clinical study titled "Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial 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 i...

What is the current status of trial NCT00318643?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-03-30. Estimated completion is 2009-08-11.

What conditions does trial NCT00318643 study?

This clinical trial studies the following conditions: Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00318643?

The interventions under investigation include: Mitomycin C (DRUG), Chemophase (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00318643?

This trial is sponsored by Halozyme Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00318643 being conducted?

This trial has 5 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial