NCT02850419

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

Heat-Activated Target Therapy (Radiotherapy + Hyperthermia + Lyso-Thermosensitive Liposomal Doxorubicin) of Local-Regional Relapse in Breast Cancer Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Imunon · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Locoregional recurrence of breast cancer (LRR) after mastectomy is a clinically challenging problem. Between 5% and 35% of women with operable breast cancer will experience an isolated LRR following their primary treatment, usually within 5 years of initial mastectomy. LRR or LR typically causes pain, lymphedema, and/or loss of freedom of movement. Therapeutic options usually involve resection, radiation or, at some specialized centers, combined radiation and hyperthermia. However, local control remains suboptimal in previously irradiated chest wall patients with the combination of radiation and hyperthermia providing local control rates of about 65%. Lyso-thermosensitive liposomal doxorubicin (LTLD) is a temperature sensitive liposome which is systemically administered and is engineered to selectively release its doxorubicin contents when exposed to temperatures ≥ 39.5°C. Local mild hyperthermia (40 to 44°C) is cytotoxic and is known to have an immunomodulatory effect along with a radiation and chemosensitizing effect in the heated tissue. Furthermore, mild hyperthermia enhances leakiness of tumor tissue, increases local perfusion and upregulates transvascular transport of doxorubicin. Radiation therapy will be administered in this combination therapy. This study evaluates the application of a tri-modal approach with LTLD to improve outcome: radiation, hyperthermia, and targeted release of a novel formulation of doxorubicin.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	ThermoDox (Thermally Sensitive Liposomal Doxorubicin)	A dose of 40 mg/m2 will be administered at each cycle for a total of 6 cycles. ThermoDox will be administered in conjunction with hyperthermia.
RADIATION	Radiation Therapy	A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.
DEVICE	Superficial Hyperthermia	Thermal dose is an one-hour treatment at a temperature between 40 and 43 degrees Celsius at the target site.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2016-08-01
• Last updated: 2022-04-07

Locations

3 sites across 3 countries: Czechia, Israel, Italy

Regulatory

• FDA-regulated drug study