A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

NCT00001381 | Completed Phase 1

• 2 other identifiers: 94009894-C-0098
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Neoplasms; Carcinoma, Transitional Cell

Keywords

Adult; Intravesical Chemotherapy

Interventions

suramin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 1512858 BACKGROUND

• 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.

  PMID: 8738403 BACKGROUND

• 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.

  PMID: 7933214 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

Suramin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: March 1, 1994
• Study Completion: December 1, 2000
• Last Updated: March 4, 2008

Record last verified: 2000-01

Locations

US (1)