Clinical Protocols in Hyperthermia at Duke Comprehensive Cancer Center:

Cervical Cancer – Soft Tissue Sarcomas – Breast Cancer

We currently have investigative protocols for patients with the following diseases:

• Carcinoma of the Cervix, locally advanced
• Soft Tissue Sarcomas, locally advanced either on the extremity or elsewhere
• Breast Cancer, post mastectomy chest wall recurrence

Please contact us to discuss your eligibility for a particular study.

All clinical trials are approved by the National Cancer Institute and Duke University’s Institutional Review Board for protection of human subjects.

CARCINOMA OF THE CERVIX

1. An International Phase III Study of Chemoradiotherapy versus Chemoradiotherapy plus Hyperthermia for Locally Advanced Cervical Cancer

   This is a phase III international multicenter study. Currently there are two American and three European institutions participating. Patients with locally advanced cervical carcinoma over age of 18 who did not have undergone surgical resection for the primary tumor nor had any previous radiation treatment are eligible. The study will compare the effectiveness of combining chemotherapy and radiation with or without hyperthermia therapy. In order to do so patients will be randomly (by chance) assigned to two separate groups of treatment (treatment arms): one group will receive chemotherapy and radiation only; another group will receive chemotherapy, radiation and hyperthermia. Neither the patient or the investigator can choose the treatment arm, therefore there is a 50% chance that some participants will not receive hyperthermia.

SOFT TISSUE SARCOMAS

1. Magnetic resonance based noninvasive thermometry for hyperthermia treatment of extremity soft tissue sarcomas

   This protocol is designed for patients with newly diagnosed soft tissue sarcomas who have had no prior treatment. Metastatic disease does not exclude enrollment provided a minimum life expectancy of at least 6 months is estimated. Patients must have an intermediate to high grade soft tissue sarcoma (grade 2 or 3). Treatment involves chemotherapy (Ifosfamide) followed by external beam radiation with hyperthermia, followed by surgery and additional postoperative chemotherapy (Adriamycin). Chemotherapy could be optional upon recommendation from the treating physician.

2. Randomized study comparing neoadjuvant chemotherapy (Etoposide plus Ifosfamide plus Adriamycin (EIA)) combined with regional hyperthermia vs. neoadjuvant chemotherapy alone in the treatment of high risk soft tissue sarcoma in adults.

   This is a phase III trial which we are conducting in collaboration with several European hyperthermia centers. Patients with sarcomas located on the extremities, body trunk or retroperitoneum are eligible. Patients must have intermediate or high grade tumor histology. Patients who have received prior chemotherapy are not eligible. Patients with distant metastases are not eligible. This is a randomized study which means there is a 50% chance that you may receive the chemotherapy, radiation and surgery treatment without hyperthermia. This study is designed to test whether the addition of hyperthermia improves the local control or overall survival, without increasing morbidity of standard treatment.

BREAST CANCER

1. A Phase I, Dose Escalation and Pharmacokinetics Study of Temperature Sensitive Liposome Encapsulated-doxorubicin (ThermoDoxTM ) and Hyperthermia on Patients with Local-Regionally Recurrent Breast Cancer
   
   This is a phase I clinical trial which main purpose is to determine the highest dose of the study drug ThermoDoxTM that can be given at the same time with hyperthermia without causing severe side effects. ThermoDoxTM is a temperature sensitive liposome-encapsulated (coated) doxorubicin. The coating is specially designed to release the drug when heated.
   
   Eligible patients are those with recurrent/metastatic breast cancer with clinical and biopsy proven disease of the chest wall who have failed at least one course of hormonal therapy (if tumor is ER or PR positive) and chemotherapy for metastatic disease. Treatment consists of six cycles of ThermoDoxTM infusion and hyperthermia to the chest wall given every 21 days.