Clinical and Pharmacological Study With 2B3-101 in Patients With Breast Cancer and Leptomeningeal… (NCT01818713) | Clinical Trial Compass
UnknownPhase 2
Clinical and Pharmacological Study With 2B3-101 in Patients With Breast Cancer and Leptomeningeal Metastases
Netherlands6 participantsStarted 2013-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. Radiological or cytological evidence of clinically LM of pathologically confirmed breast cancer.
✓. Concomitant brain metastases are allowed
✓. ECOG Performance Status ≤ 2.
✓. Estimated life expectancy of at least 8 weeks.
✓. Stable/decreasing dosage of steroids (e.g.dexamethasone) for 7 days prior to baseline MRI.
✓. Use of non-enzyme inducing anti-epileptic drugs is allowed.
✓. Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 2 (as defined by CTCAE version 4.0).
Exclusion criteria
✕. Less than 4 weeks from the last treatment of chemotherapy, biological therapy, immunotherapy, endocrine therapy and less than 6 weeks for nitrosoureas and mitomycin C.
What they're measuring
1
- safety and preliminary response using the "LM response score" during the 2B3-101 treatment in patients with LM from breast cancer.
. Less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equine.
✕. Patients that have received a maximum cumulative dose of free (i.e., non-liposomal) or liposomal doxorubicin \> 360mg/m2 or free epirubicin \> 600mg/m2
✕. Current or recent (less than 4 weeks before first 2B3-101 treatment) treatment with another investigational drug.
✕. Any other current anticancer therapy
✕. Inadequate bone marrow function, defined as: Absolute Neutrophil Count (ANC): \< 1.5 x 109/L, or platelet count \< 100 x 109/L or haemoglobin \< 6 mmol/L.