We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    thermodox rcw
Previous Study | Return to List | Next Study

Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall (DIGNITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00826085
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):

Brief Summary:
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ThermoDox in combination with Microwave Hyperthermia (heat) Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Evaluating the Maximum Tolerated Dose, Bioequivalence/Pharmacokinetics, Safety, and Efficacy of Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Local-Regional Recurrent Breast Cancer.
Actual Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer Fever

Arm Intervention/treatment
Experimental: Thermodox in combination with hyperthermia
Single arm study
Drug: ThermoDox in combination with Microwave Hyperthermia (heat)

ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion.

Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system.

All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals.

Primary Outcome Measures :
  1. To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer. [ Time Frame: PK collection at Cycle 1 and Cycle 2 ]
  2. To determine efficacy of ThermoDox in combination with Hyperthermia [ Time Frame: Efficacy assessed at Cycle 3, Cycle 5 and End of Treatment ]

Secondary Outcome Measures :
  1. To evaluate the safety of ThermoDox in combination with Hyperthermia [ Time Frame: Through 6 treatment Cycles ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):

    • Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible.
    • Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
    • Breast carcinoma for medical reasons not being resected
  2. Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
  3. Disease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:

    • One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
  4. Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
  5. Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:

    • They have received standard anti-tumor treatment for their brain metastases without encephalopathy;
    • Their neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.
  6. Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
  7. Provide written informed consent and willing to comply with protocol requirements.

Exclusion Criteria:

  1. Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
  2. Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
  3. Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received):

    Free (i.e., non-liposomal) or liposomal doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.

  4. Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
  5. Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):

    • ANC Granulocytes < 1,500/ microliter
    • Platelets < 75,000/ microliter
    • Hemoglobin < 9 gm/dL
    • Total Bilirubin > 2 mg/dL
    • ALT and AST > 2.5 X upper limit of normal
    • Creatinine > 1.5 X upper limit of normal.
  6. ECOG/Zubrod Performance Status > 2.
  7. MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
  8. Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
  9. History of:

    • Acute coronary syndrome
    • Cerebral vascular accident
    • Abnormal cardiac stress testing within last 6 months
    • Symptomatic coronary artery disease
    • Uncontrolled hypertension or cardiomyopathy
    • Cardiac valvular surgery or open heart surgery
    • Known structural heart disease.
  10. Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
  11. Active infection requiring antibiotic treatment
  12. Has received any external radiation therapy within 28 days prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826085

Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Oklahoma
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Layout table for investigator information
Study Director: Nicholas Borys, MD Imunon
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Imunon
ClinicalTrials.gov Identifier: NCT00826085    
Other Study ID Numbers: 105-08-201
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Keywords provided by Imunon:
Breast Cancer
Recurrent Chest Wall Cancer
Loco-regional Recurrent Breast Cancer
Breast Cancer Recurrence at the Chest Wall
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries