Pilot Study of a Catheter-based Ultrasound Hyperthermia System

NCT00911079 | Terminated DMC FDA Device

• 3 other identifiers: CDR0000643085089925R01CA122276
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer; Prostate Cancer

Keywords

Stage III, IV cervical cancer; Rising prostate specific antigen (PSA) after local therapy

Outcome Measures

Primary Outcomes (3)

• Frequency of treatment-related toxicities by treatment type

  All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.

  Up to 3 months

• Frequency of treatment-related toxicities by accrual plan

  All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer

  Up to 3 months

• Proportion of patients treated according to the specified temperature and timing criteria.

  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

  Up to 4 weeks

Secondary Outcomes (5)

• Average maximum prostate temperature (Tmax)

  Up to 4 weeks

• Minimum temperature (Tmin)

  Up to 4 weeks

• Median temperature (T50)

  Up to 4 weeks

• Number of times temperature exceeded by 90% of the measured temperature points (T90)

  Up to 4 weeks

• Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)

  Up to 4 weeks

Study Arms (1)

Hyperthermia with HDR brachytherapy

EXPERIMENTAL

Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session

Procedure: Hyperthermia; Radiation: HDR brachytherapy

Interventions

Hyperthermia PROCEDURE

Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)

Hyperthermia with HDR brachytherapy

HDR brachytherapy RADIATION

Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Hyperthermia with HDR brachytherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-1708, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Prostatic Neoplasms; Salivary Gland Adenoma, Pleomorphic

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• I-Chow J. Hsu, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 1, 2009
• Study Start: December 18, 2009
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)