Search / Trial NCT00001381

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Adult Intravesical Chemotherapy

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001381_2024-06-14.pdf

4.5 MB

NCT00001381_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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