Pilot Study of a Catheter-based Ultrasound Hyperthermia System (08992)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
I-Chow Hsu, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00911079
First received: May 29, 2009
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.


Condition Intervention
Cervical Cancer
Prostate Cancer
Procedure: Hyperthermia
Radiation: HDR brachytherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy [ Time Frame: baseline to completion of study ] [ Designated as safety issue: Yes ]
    All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all adverse events will be tabulated by type and presented separately for the first and second hyperthermia treatments. In addition, the safety data will be presented for the 2 subsets of patients corresponding to the plan for accrual for gynecological and prostate cancer subgroups: the first 3 patients in each subgroup, then the final 9 patients.


Secondary Outcome Measures:
  • Evaluate the feasibility, defined as being able to administer hyperthermia at a specified temperature range and thermal dose. [ Time Frame: baseline to completion of study ] [ Designated as safety issue: No ]
    The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions.

  • Characterize the interstitial and endocavitary ultrasound heating technology by describing the thermal parameters including attainable temperature and thermal dose distribution and duration at the tumor treatment region. [ Time Frame: baseline to completion of study ] [ Designated as safety issue: No ]
    Parameters quantifying the therapeutic heat and thermal dose delivered to the tumor treatment regions encountered in the brachytherapy setting will be calculated. Thermal parameters as determined by thermometry measurements will be recorded at each of the two hyperthermia sessions (Tmax, Tmin, T50, T90, CEM (43)T(90). These values will be used to evaluate radial temperature and thermal dose profiles through the clinical target volume for each treatment. Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment and possibly by type of cancer (gynecologic or prostate).


Estimated Enrollment: 24
Study Start Date: April 2009
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperthermia with HDR brachytherapy
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
Procedure: Hyperthermia
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)
Radiation: HDR brachytherapy
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Detailed Description:

OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.

After completion of study therapy, patients are followed at 1 and 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:

  • Cervical cancer Stage III or IV OR
  • Prostate cancer (with rising prostate specific antigen after prior local therapy)

Age ≥18 years

Eligible for brachytherapy as determined per clinical standard of care.

Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion Criteria:

Patients who are not candidates for HDR brachytherapy

Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911079

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94143-1708
Contact: I-Chow J. Hsu, MD    415-353-7106    ihsu@radonc.ucsf.edu   
Contact: Christian J Diederich, PhD    415-476-8641    cdiederich@radonc.ucsf.edu   
Sub-Investigator: Christian J Diedrich, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: I-Chow J. Hsu, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: I-Chow Hsu, Professor, Radiation Oncology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00911079     History of Changes
Other Study ID Numbers: CDR0000643085, 08992, R01CA122276
Study First Received: May 29, 2009
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Stage III, IV cervical cancer
Rising prostate specific antigen (PSA) after local therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Uterine Cervical Neoplasms
Fever
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014