Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer

NCT00734994 | Completed Early Phase 1 Results

• 1 other identifier: Pro00003239
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transitional Cell Carcinoma of Bladder; Superficial Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.

  During Treatment Phase average 6 weeks

Secondary Outcomes (1)

• Median Recurrence Free-survival

  Median follow-up 3.18 years

Study Arms (1)

Hyperthermia system, Mitomycin C

EXPERIMENTAL

Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.

Device: Hyperthermia System; Drug: Mitomycin C

Interventions

Hyperthermia System DEVICE

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

Also known as: BSD 2000 Hyperthermia system

Hyperthermia system, Mitomycin C

Mitomycin C DRUG

40 mg in 40 ml sterile water instilled into bladder

Also known as: Mutamycin

Hyperthermia system, Mitomycin C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Dewhirst: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Juang T, Stauffer PR, Craciunescu OA, Maccarini PF, Yuan Y, Das SK, Dewhirst MW, Inman BA, Vujaskovic Z. Thermal dosimetry characteristics of deep regional heating of non-muscle invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):176-83. doi: 10.3109/02656736.2014.898338. Epub 2014 Mar 26.

  PMID: 24669804 BACKGROUND

• Yuan Y, Cheng KS, Craciunescu OI, Stauffer PR, Maccarini PF, Arunachalam K, Vujaskovic Z, Dewhirst MW, Das SK. Utility of treatment planning for thermochemotherapy treatment of nonmuscle invasive bladder carcinoma. Med Phys. 2012 Mar;39(3):1170-81. doi: 10.1118/1.3679839.

  PMID: 22380348 BACKGROUND

• Inman BA, Stauffer PR, Craciunescu OA, Maccarini PF, Dewhirst MW, Vujaskovic Z. A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer. Int J Hyperthermia. 2014 May;30(3):171-5. doi: 10.3109/02656736.2014.882021. Epub 2014 Feb 3.

  PMID: 24490762 RESULT

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Brant A. Inman, MD, MS
• Organization: Duke University, Division of Urology

brant.inman@duke.edu

919 684-1322

Study Officials

• Zelko Vujaskovic, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Brant A Inman, MD, MS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: August 14, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 29, 2015
• Results First Posted: August 30, 2011

Record last verified: 2015-06

Locations

US (1)