Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
NCT00006034 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2013-05-15
Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether keyhole limpet hemocyanin is more effective than doxorubicin for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG.
Conditions
Interventions
- BIOLOGICAL
-
keyhole limpet hemocyanin
Given intradermally and IV
- DRUG
-
doxorubicin hydrochloride
Given IV
Sponsors & Collaborators
-
Intracel
lead INDUSTRY
Principal Investigators
-
Michael G Hanna Jr., PhD · Intracel
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-06-30
- Completion
- 2004-03-31
Countries
- United States
Study Locations
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