Clinical and Pharmacological Study With 2B3-101 in Patients With Breast Cancer and Leptomeningeal Metastases
Status:
Unknown status
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Leptomeningeal metastases (LM) develop when tumor cells reach the cerebrospinal fluid (CSF)
and infiltrate the leptomeninges. The median survival of patient with breast cancer and LM is
4-6 months with up to 25% long-term survivors. Many potentially highly efficacious
intravenous chemotherapies are currently not effective to treat LM because they do not
adequately cross the blood-CSF barrier.
Doxorubicin, the anthracycline chemotherapeutic agent, has a well-established antineoplastic
activity in breast cancer. To optimally enhance the delivery of liposomal doxorubicin to the
brain, to-BBB technologies B.V. has designed a glutathione (GSH) pegylated liposomal
doxorubicin hydrochloride formulation (2B3-101). Coating of liposomes with PEG ensures the
prolonged circulation time in plasma, whilst conjugation of GSH to the tips of the PEG
molecules targets the liposomes towards the active GSH transporters on the BBB to enhance the
delivery of doxorubicin to the brain.
This is a a clinical and pharmacological study that aims to determine preliminary efficacy of
treatment with 2B3-101 in patients with leptomeningeal metastases of breast cancer using the
LM response score.