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

NCT01240824 | Completed Early Phase 1 DMC

• 1 other identifier: 14585
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Bladder Cancer

Keywords

bladder cancer; urothelial carcinoma; transitional cell carcinoma bladder; ureter

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  Any cardiac arrythmia or seizure activity, \> grade 2 allergic reactions, fever 101.5 for \> 48 hours, \> grade 1 insomnia, \> grade 1 involuntary movements, \> grade 2 nausea / vomiting, \> grade 2 bladder spasms, dysuria or pelvic pain.

  Week 6

Study Arms (1)

BCG + aminophylline

EXPERIMENTAL

Bacillus Calmette-Guerin (BCG) plus one of three escalating doses of aminophylline administered intravesically.

Drug: aminophylline

Interventions

aminophylline DRUG

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

BCG + aminophylline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 40 years of age because in patients younger than that the natural history is different.
• Histologically proven bladder cancer that is NOT muscle invasive (Ta or T1)
• Transurethral resection of Bladder Tumor (TURBT) at least 2 weeks prior to first instillation
• ECOG performance status of 0 or 1.
• Informed consent obtained from patient before enrollment.
• English is primary language
• Patients undergoing initial 6 week BCG therapy (BCG naïve)
• Patients undergoing 3 week BCG maintenance therapy.

You may not qualify if:

• Hypersensitivity reaction or contraindication to aminophylline or theophylline
• Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding).
• Hepatic insufficiency as defined by an abnormal AST or ALT.
• Known arrhythmias or heart failure as defined by class II or greater cardiovascular disease according to the New York Heart Associations functional criteria
• Immunocompromised
• Seizure disorder.
• Current treatment with oral theophylline or any other methylxanthine derivative.
• Active urinary tract infection by nitrite positive urine dip or gross hematuria
• Reduced dosing of BCG or BCG failures who have experienced bladder cancer recurrrence.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Urology Department

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

Aminophylline

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)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Tracy L Krupski, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

US (1)