Clinical trial · Interventional
Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
A Phase I, Dose Escalation and Pharmacokinetics Study of Temperature Sensitive Liposome Encapsulated Doxorubicin (ThermoDox™) and Hyperthermia in Patients With Local-Regionally Recurrent Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| lyso-thermosensitive liposomal doxorubicin(Thermodox) | Drug | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thermodox
- description
- ThermoDox20-40mg/m2 every 21-35 days followed by Chest Wall Hyperthermia
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: lyso-thermosensitive liposomal doxorubicin(Thermodox)
- Procedure: hyperthermia treatment
Primary outcomes (1)
- measure
- Maximum tolerated dose of temperature-sensitive liposomal doxorubicin (ThermoDox™) in combination with hyperthermia
- timeFrame
- 4 years
Secondary outcomes (1)
- measure
- Pharmacokinetics
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (2)
- RESULTNolen BM, Marks JR, Ta'san S, Rand A, Luong TM, Wang Y, Blackwell K, Lokshin AE. Serum biomarker profiles and response to neoadjuvant chemotherapy for locally advanced breast cancer. Breast Cancer Res. 2008;10(3):R45. doi: 10.1186/bcr2096. Epub 2008 May 12. PMID 18474099
- DERIVEDZagar TM, Vujaskovic Z, Formenti S, Rugo H, Muggia F, O'Connor B, Myerson R, Stauffer P, Hsu IC, Diederich C, Straube W, Boss MK, Boico A, Craciunescu O, Maccarini P, Needham D, Borys N, Blackwell KL, Dewhirst MW. Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer. Int J Hyperthermia. 2014 Aug;30(5):285-94. doi: 10.3109/02656736.2014.936049. PMID 25144817