NCT00006476

Brief Summary

RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 26, 2013

Status Verified

March 1, 2007

First QC Date

November 6, 2000

Last Update Submit

June 25, 2013

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancerrecurrent bladder cancer

Interventions

suraminDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven recurrent superficial bladder cancer * Intermediate prognosis as defined by the following: * Recurrent, multiple Ta, T1 carcinoma * Multiple (1-7) tumors * Tumors resected previously must be histological grade G1 or G2 OR * Previously treated superficial bladder cancer requiring followup cystoscopy * Recurrent disease diagnosed at surgery * No tumor invasion into muscle or carcinoma in situ PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm3 * Platelet count at least 150,000/mm3 Hepatic: * No clinically significant hepatic disease Renal: * Creatinine clearance greater than 60 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No history of adrenal insufficiency * No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer * No history of difficult catheterization * No confusion or disorientation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy to the bladder * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major thoracic or abdominal surgery Other: * Recovered from prior therapy and stable for 4 weeks * At least 6 weeks since prior intravesicular therapy * No prior or concurrent investigational drugs * No concurrent anticoagulants

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

Sponsors & Collaborators

Study Sites (1)

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Related Publications (1)

  • Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7. doi: 10.1038/sj.bjc.6602650.

    PMID: 15928663RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Suramin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • Adrian L. Harris, MD

    Oxford University Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

January 27, 2003

Study Start

October 1, 2000

Study Completion

October 1, 2007

Last Updated

June 26, 2013

Record last verified: 2007-03

Locations

GB(1)