Overview

Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients

Status:
Suspended
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
Female
Summary
The 105-15-201 study is designed to assess the effectiveness and tolerability of the combination of heat-activated target therapy (radiotherapy + hyperthermia + lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celsion
Treatments:
Doxorubicin
Liposomal doxorubicin
Criteria
Inclusion Criteria:

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

- Ulcerative chest wall disease defined as non-healing wounds consistent with
cancer.

- Inflammatory breast carcinoma.

- Breast carcinoma not resected for medical reasons.

2. Tumor thickness, must be clinically indicated for hyperthermia therapy, as measured by
clinical exam or radiological imaging studies (CT or MRI). The target local tumor
lesion(s) must be able to be covered within two hyperthermia fields of treatment.

3. LRR Disease progression 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

4. Patients with stable distant bone metastasis; concomitant treatment with Zoledronic
acid and Denosumab is allowed

5. Non-pregnant female at least 18 years of age. If 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.

6. Provide written informed consent and willing to comply with the protocol requirements.

Exclusion Criteria:

1. No concomitant cytotoxic antineoplastic therapy is allowed. Prior chemotherapy should
not be administered within 5 half-lives or 28 days whichever is shorter.

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. Patients who have previously received hyperthermia in conjunction with either
radiation therapy or chemotherapy.

4. Previous treatment with anthracyclines exceeding the following dosages: free
doxorubicin (i.e. non- liposomal) and/or liposomal doxorubicin ≥300 mg/m2 epirubicin
free > 540 mg / m2.

5. 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.

6. Baseline laboratories (to establish eligibility): · Granulocytes ......< 1,500/
microliter · Platelets .......... < 75,000/ microliter · Hemoglobin ... < 9 gm/dL
Total Bilirubin ... > 2 mg/dL ALT and AST ...> 2.5X upper limit of normal Creatinine
......... > 1.5 X upper limit of normal.

7. ECOG/Zubrod Performance Status > 2.

8. MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.

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 and cardiac valvular surgery or open heart surgery.

10. Conditions which may interfere with 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/CW.

11. Serious active infection requiring long-term antibiotic treatment.

12. Has received any external radiation therapy within 60 days prior to study enrollment.

13. Patients with parenchymal and known brain metastases; if metastasis is operated or
irradiated the patient can be included in the study.