Expired Study
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Durham, North Carolina 27710


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.


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


Study is Available At:


Original ID:

Pro00003239


NCT ID:

NCT00734994


Secondary ID:


Study Acronym:


Brief Title:

Mitomycin C With Hyperthermia for Non-muscle Invasive Bladder Cancer


Official Title:

Pilot Study of External Hyperthermia and Intravesical Mitomycin-C To Treat Recurrent Bladder Cancer After Resection and Standard Adjuvant Therapy


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Zeljko Vujaskovic, MD, PhD
Principal Investigator
Duke University

Study Dates

Start Date:April 2008
Completion Date:September 2011
Completion Type:Anticipated
Primary Completion Date:February 2011
Primary Completion Type:Anticipated
Verification Date:October 2010
Last Changed Date:October 13, 2010
First Received Date:May 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To estimate the time to second recurrence using this thermo intravesical chemotherapy treatment regimen.
Time Frame:1 year
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:BSD 2000 Hyperthermia System
Description: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
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Mitomycin C and Hyperthermia

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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