Status:
COMPLETED
Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall
Lead Sponsor:
Imunon
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
Breast cancer is the most common malignancy in women in both the United States and the world. Despite a variety of hormonal, cytotoxic and biologic approaches, a significant number of tumors will recu...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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).
- Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
- 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.
- 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.
- Provide written informed consent and willing to comply with protocol requirements.
Exclusion
- 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).
- 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.
- 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.
- 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.
- 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.
- ECOG/Zubrod Performance Status \> 2.
- MUGA/Echocardiogram Left Ventricular Ejection Fraction \< 50%.
- 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.
- 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.
- 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.
- Active infection requiring antibiotic treatment
- Has received any external radiation therapy within 28 days prior to enrollment.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00826085
Start Date
February 1 2013
End Date
June 1 2016
Last Update
January 30 2017
Active Locations (6)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
3
University of Maryland
Baltimore, Maryland, United States, 21201
4
Washington University in St. Louis
St Louis, Missouri, United States, 63110