A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Study Details
Study Description
Brief Summary
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Institute (NCI) | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- 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. Review.
- 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.
- 940098
- 94-C-0098