Clinical trial NCT00346229 (phase 1, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: lyso-thermosensitive liposomal doxorubicin(thermodox)
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Reason stopped: 
    funding
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast

               -  Locally recurrent disease involving the chest wall and/or its overlying skin

                    -  Clinically and biopsy proven disease on the chest wall area measuring ≥ 1 cm

                    -  Overall surface extent of tumor ≤ two 16 x 16 cm fields

                    -  Tumor thickness ≤ 3 cm by clinical exam and CT scan or MRI

                    -  Disease extent on the chest wall that exceeds the above criteria allowed
                       provided no other local therapies are available

                    -  Patients with axillary disease involvement only must meet the above criteria
                       in order to be eligible

                    -  Prior skin changes consistent with inflammatory breast cancer are allowed

          -  Distant metastasis (excluding known brain metastases) allowed

               -  No resectable chest wall recurrence as the only site of metastatic disease

               -  No refractory pain secondary to metastatic disease

          -  Must have undergone prior local radiotherapy to the chest wall or breast in the
             adjuvant or metastatic setting

          -  Must have progressed on ≥ 1 course of hormonal therapy for metastatic disease (if
             tumor is estrogen receptor positive or progesterone receptor positive) AND ≥ 1 course
             of chemotherapy

          -  Prior contralateral breast malignancy allowed provided not previously treated with
             chemotherapy

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Female

          -  Menopausal status not specified

          -  Zubrod performance status 0-1 OR Karnofsky performance status 90-100%

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin normal

          -  alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper
             limit of normal (ULN)

          -  Creatinine ≤ 1.5 times ULN

          -  left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan
             (MUGA) or echocardiogram

          -  No nonhealing wounds or active infection in the area of the chest wall

          -  No clinically significant findings on baseline evaluations, including laboratory and
             physical examinations, vital signs, and ECG

          -  No prior sensitivity (e.g., rash, dyspnea, wheezing, urticaria, or other symptoms)
             attributed to anthracyclines or other liposomally encapsulated drugs

          -  No other prior or concurrent primary malignancy except for melanoma in situ,
             nonmelanoma skin cancer, squamous cell carcinoma, or noninvasive cervical carcinoma

          -  No history of any of the following:

               -  Cardiac ischemia or acute coronary artery syndrome, myocardial infarction (MI),
                  cerebral vascular accident, or abnormal cardiac stress testing within the last 6
                  months

               -  Coronary artery disease (including non-Q wave MI)

               -  Uncontrolled hypertension or cardiomyopathy

               -  Cardiac valvular surgery or open heart surgery

               -  Known structural heart disease

          -  No other serious medical illness including, but not limited to, the following:

               -  Congestive heart failure

               -  Life-threatening cardiac arrhythmias

               -  Acute or chronic liver disease

          -  No major psychiatric illness that required inpatient treatment within the past 3
             months or that would preclude obtaining informed consent

          -  No concurrent devices or conditions that might interfere with the hyperthermia portion
             of the trial, including any of the following:

               -  Functioning cardiac pacemaker

               -  Metal plates, rods, or prosthesis of the chest wall

               -  Severe numbness and/or tingling of the chest wall or breast

               -  Skin grafts and/or flaps on the breast or chest wall

               -  Unstable cardiovascular or pulmonary status

          -  No known allergy to eggs or egg products

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 3 months since prior major surgery

          -  No prior therapy with anthracyclines exceeding the following doses:

               -  Doxorubicin hydrochloride > 450 mg/m^2

               -  Epirubicin hydrochloride > 900 mg/m^2

          -  More than 42 days since prior trastuzumab (Herceptin®)

          -  More than 90 days since prior radiotherapy to the involved chest wall area

          -  No other concurrent systemic anticancer therapy, including hormonal therapy,
             chemotherapy, or investigational anticancer therapy

          -  No concurrent radiotherapy, including radiotherapy for pain control

          -  No concurrent administration of any of the following drugs:

               -  Amphotericin B by injection

               -  Antithyroid agents

               -  Azathioprine

               -  Chloramphenicol

               -  Colchicine

               -  Flucytosine

               -  Ganciclovir

               -  Interferon

               -  Plicamycin

               -  Zidovudine

               -  Sulfinpyrazone

               -  Probenecid

               -  Cyclosporine

               -  Phenobarbital

               -  Phenytoin

               -  Streptozocin

               -  Live vaccines

          -  Concurrent bisphosphonates for palliation of bony metastasis allowed