- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001381
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion.
Clinically useful pretreatment bladder function required.
No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying.
No active urinary tract infection.
PRIOR/CONCURRENT THERAPY:
At least 1 course of prior standard intravesical therapy required.
At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0 or 1.
Hematopoietic:
WBC at least 3,300;
Hemoglobin at least 10 g/dL.
Hepatic:
Bilirubin no greater than 1.5 mg/dL;
AST and ALT no greater than 2 times normal.
Renal: Creatinine no greater than 1.5 mg/dL.
OTHER:
Medically able to undergo cystoscopy.
No pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gansler T, Vaghmar N, Olson JJ, Graham SD. Suramin inhibits growth factor binding and proliferation by urothelial carcinoma cell cultures. J Urol. 1992 Sep;148(3):910-4. doi: 10.1016/s0022-5347(17)36776-9.
- Walther MM, Figg WD, Linehan WM. Intravesical suramin: a novel agent for the treatment of superficial transitional-cell carcinoma of the bladder. World J Urol. 1996;14 Suppl 1:S8-11. doi: 10.1007/BF00182057.
- Walther MM, Trahan EE, Cooper M, Venzon D, Linehan WM. Suramin inhibits proliferation and DNA synthesis in transitional carcinoma cell lines. J Urol. 1994 Nov;152(5 Pt 1):1599-602. doi: 10.1016/s0022-5347(17)32486-2.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Anti-Infective Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Trypanocidal Agents
- Suramin
Other Study ID Numbers
- 940098
- 94-C-0098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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