Local-Regional Relapse in Breast Cancer MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ThermoDox(R)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOXORUBICINA CLORIDRATO
CAS Number: 25316-40-9
Current Sponsor code: 105-15-201
Other descrip
Sponsors
CELSION CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically documented recurrent denocarcinoma 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 childbearing 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 protocol requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
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 or 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): •ANC Granulocytes 2 mg/dL •ALT and AST > 2.5 X 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 •Cardiac valvular surgery or open heart surgery •Known structural heart disease 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/chest wall. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the safety and tolerability of the combination of ThermoDox + Hyperthermia + Radiotherapy among patients with locoregional recurrent breast cancer. - To evaluate loco-regional breast tumor control in patient who underwent ThermoDox + Hyperthermia + Radiotherapy as measured by target lesion clinical response rate combining RECIST criteria with digital photography to gauge response.;Secondary Objective: (partial response) and SD (stable disease) following treatment with ThermoDox + Hyperthermia + Radiotherapy up to 12 months among patients with loco-regional breast cancer. - To assess Patient Reported Quality of Life using the FACT-B and Brief Pain Inventory (BPI) following treatment with ThermoDox + Hyperthermia + Radiotherapy among patients with loco-regional breast cancer.;Primary end point(s): Objective Tumor Response Evaluation for Assessing Breast and Chest Wall lesions using RECIST criteria Safety and Tolerability assessment with the combination of ThermoDox, hyperthermia and radiation therapy.;Timepoint(s) of evaluation of this end point: Cycle 3, Cycle 5, EOT and Follow-up for up to 1 year From baseline through EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of local control [CR (complete response), PR (partial response) and SD (stable disease) following treatment with ThermoDox + Hyperthermia + Radiotherapy up to 12 months among patients with LRR breast cancer. Assess Patient Reported Quality of Life;Timepoint(s) of evaluation of this end point: From Baseline to Follow-Up From Baseline to EOT | — |
Countries
Israel, Italy
Contacts
Public ContactAss. Director, Clinical Operations
Celsion Corporation
Outcome results
None listed