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


Phase 0
18 Years
75 Years
Not Enrolling
Both
Transitional Cell Carcinoma of Bladder, Superficial Bladder Cancer

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Trial Information

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


It is well established that tumor cells are sensitive to heat and when combined with a
chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant
cells is improved due to increased cellular permeability. Further, hyperthermia inhibits
deoxyribonucleic acid (DNA) repair as a result of increased reaction between DNA and
chemotherapy. By heating bladder tissue and accelerating the necessary series of reactions
to link agents such as mitomycin C to cell DNA, this effect may be optimized. Depending on
the extent of resection (and location, size, and depth of invasion of remaining tumor) after
transurethral resection of the bladder tumor(TURBT), recommended adjuvant therapy consists
of intravesical chemotherapy. MMC has been studied at doses as high as 80 mg without
producing significant or irreversible side effects. The most commonly used dose of mitomycin
is 40 mg.2

This pilot study proposes to use Mitomycin C at a dose of 40 mg in conjunction with deep
hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of
recurrent TCC (Stage Ta, T1, or Tis) of the bladder after surgical resection and standard
adjuvant therapy.


Inclusion Criteria:



- Non-muscle invasive transitional cell carcinoma (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 Bacillus Calmette Guerin (BCG)
solution); or

- An inability to tolerate BCG

- Age > 18

- Eastern Cooperative Oncology Group(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), Asparate Aminotransferase(AST) and Alanine Aminotransferase(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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Number of patient treatments stopped due to safety concerns including side effect such as heat sensations or burning in the pelvis, intolerance to heat, weight of the water bolus on the abdomen, or supine position.

Outcome Time Frame:

During Treatment Phase average 6 weeks

Safety Issue:

Yes

Principal Investigator

Zeljko Vujaskovic, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00003239

NCT ID:

NCT00734994

Start Date:

April 2008

Completion Date:

March 2011

Related Keywords:

  • Transitional Cell Carcinoma of Bladder
  • Superficial Bladder Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Fever

Name

Location
Duke University Medical Center Durham, North Carolina  27710