EUCTR2012-005096-13-NL
Active, Not Recruiting
N/A
Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer and leptomeningeal metastases
the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)0 sitesNovember 21, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \= 18 years.
- •2\. Radiological or cytological evidence of clinically symptomatic leptomeningeal metastases of breast cancer.
- •3\. Stable or decreasing dosage of steroids (e.g.dexamethason) for 7 days prior to baseline MRI or non\-enzyme inducing anti\-epileptic drugs is allowed.
- •4\. Concomitant brain metastases are allowed
- •5\. Patients with pathologically confirmed diagnosis of advanced, recurrent breast cancer and unequivocal evidence of leptomeningeal metastases
- •6\. ECOG Performance Status \= 2\.
- •7\. Estimated life expectancy of at least 8 weeks.
- •8\. 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\).
- •9\. Performed cognitive test for neurotoxicity
- •10\. Written informed consent according to local guidelines.
Exclusion Criteria
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist:
- •Prior Treatment:
- •1\. 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.
- •2\. Less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina. Radiotherapy of the symptomatic bone metastases is allowed during 2B3\-101 treatment but if they are located in the vertebral column, these radiated localisations cannot be used for response evaluation.
- •3\. Patients that have received a maximum cumulative dose of free (i.e., non\-liposomal) or liposomal doxorubicin \> 360mg/m2 or free epirubicin \> 600mg/m2
- •4\. Current or recent (less than 4 weeks before first 2B3\-101 treatment) treatment with another investigational drug.
- •5\. Any other current anticancer therapy is not allowed, as there are no interaction data of combination of 2B3\-101 with other anticancer agents.
- •Haematology, coagulation and biochemistry:
- •6\. Inadequate bone marrow function: Absolute Neutrophil Count (ANC): \< 1\.5 x 109/L, or platelet count \< 100 x 109/L or haemoglobin \< 6 mmol/L.
- •7\. Inadequate liver function, defined as:
Outcomes
Primary Outcomes
Not specified
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