Mitomycin C With Hyperthermia for Non-Muscle Invasive Bladder Cancer - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00734994

Purpose

Hypothesis: In selected patients external hyperthermia will be used in combination with intravesical Mitomycin-C to treat recurrent TCC of the bladder after local resection and standard adjuvant therapy and thus prevent or delay recurrence and the need for radical cystectomy.

Condition	Intervention
Non Muscle Invasive Bladder Cancer Superficial Bladder Cancer	Device: BSD 2000 Hyperthermia System

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of External Hyperthermia and Intravesical Mitomycin-C To Treat Recurrent Bladder Cancer After Resection and Standard Adjuvant Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Fever

Drug Information available for: Mitomycin Mitomycins

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

To assess the safety and tolerability of administering local bladder hyperthermia and intravesical mitomycin-C, as second-line treatment of recurrent TCC of the bladder after failing initial surgery and standard adjuvant therapy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To estimate the time to second recurrence using this thermo intravesical chemotherapy treatment regimen. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mitomycin C and Hyperthermia	Device: BSD 2000 Hyperthermia System Mitomycin C 40 mg solution instilled into bladder Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-muscle invasive TCC of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with BCG solution); or
An inability to tolerate BCG
Age > 18
ECOG Performance Status 0-2
Laboratory tests performed within 14 days of study enrollment:
- Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
- Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal *(ULN), AST and ALT ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
Women of child bearing potential must have a negative pregnancy test
If post-menopausal - Amenorrhea for ≥ 12 months

Exclusion Criteria:

Pregnancy or breastfeeding
Muscle invasive disease (T2-T4)
Prior radiation to the pelvis
Peripheral neuropathy (any grade)
Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
Known bladder fistula
Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734994

Contacts

Contact: Zeljko Vujaskovic, MD	919 668-5221	vujas001@mc.duke.edu
Contact: Wendy Covington, BS	919 668-3032	wendy.covington@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Zeljko Vujaskovic, MD 919-668-5221
Principal Investigator: Zeljko Vujaskovic, MD

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Zeljko Vujaskovic, MD, PhD

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Zeljko Vujaskovic, MD )
Study ID Numbers:	Pro00003239
Study First Received:	May 4, 2008
Last Updated:	February 22, 2009
ClinicalTrials.gov Identifier:	NCT00734994 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Adjuvants, Immunologic
Urogenital Neoplasms
Urologic Neoplasms
Mitomycins

Recurrence
Fever
Anti-Bacterial Agents
Urologic Diseases
Mitomycin
Bladder Neoplasm
Alkylating Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Antibiotics, Antineoplastic
Mitomycins

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 04, 2009