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Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer

NCT01240824 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-04-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to participate in a study where they are given the standard BCG followed by the experimental drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer patients, at the current time we do not know if it has any benefits at all. We have data in mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.

Conditions

Interventions

DRUG

aminophylline

One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Tracy L Krupski, M.D. · University of Virginia

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01240824 on ClinicalTrials.gov