Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00992602
Eligibility Criteria:
Inclusion Criteria:
* Women who are not pregnant (contraception must be used throughout the study)
* Diagnosis of breast cancer with metastases to CNS (regardless of receptor status); leptomeningeal disease must be present with/without parenchymal brain involvement
* Able to provide informed consent
* No prior treatment with whole brain radiotherapy (WBRT); if patient received stereotactic radiosurgery (SRS) prior to enrollment it must be well documented which lesions were treated and untreated index lesions for follow up must be identified; no treatment with SRS will be permitted while on the study; CNS disease must be documented by MRI and CSF cytology
* Karnofsky Performance Status \> 60
* White blood cells (WBC) \>= 3.0 K
* Absolute neutrophil count (ANC) \>= 1.5 K
* Platelets (PLT) \>= 100 K
* Hematocrit (HCT) \>= 30%
* Glomerular filtration rate (GFR) \>= 60 mL/min
* Acceptable liver function (see exclusion criteria)
* Any ongoing therapy for systemic disease allows for the addition of systemic HD-MTX and IT Depocyt; in general patients receiving trastuzumab or lapatinib at the time of enrollment will be allowed to continue; bisphosphonates (i.e., zoledronic acid) and denosumab will be allowed; other non-CNS active chemotherapies might be allowed if no known interactions with study drugs are present; this must be reviewed and approved by the primary investigator on a case-by-case basis
* Mini-mental state examination score of 24 or above
Exclusion Criteria:
* Serum bilirubin \> 1.5 x the upper limit of reference range (ULRR)
* Serum creatinine \> 1.5 x ULRR or creatinine clearance =\< 60 mL/minute (calculated by Cockcroft-Gault formula)
* Potassium, \< 3.7 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 x ULRR
* Alkaline phosphatase (ALP) \> 2.5 x ULRR or \> 5 x ULRR if judged by the investigator to be related to liver metastases
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Patients with known pleural effusion or ascites
* Prior treatment with whole brain radiotherapy (prior treatment with SRS is allowed under conditions provided in the inclusion criteria)
* Previous allergic or adverse reaction to methotrexate or cytarabine
* Prior treatment with systemic HD-MTX, IT liposomal cytarabine, or IT therapy of any kind
* Prior IT therapy of any kind
* Women who are currently pregnant or breast feeding
* Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
* Receipt of any investigational agents within 30 days prior to commencing study treatment
* Last dose of prior chemotherapy was less than 4 weeks before the start of study therapy; patients who had no toxicities with prior chemotherapy can start study treatment earlier than 4 weeks
* Stereotactic radiosurgery (SRS) less than 2 weeks before the start of study therapy
* Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy
* Previous enrollment in the present study
* Major surgery within 4 weeks prior to starting therapy, with the exception of the Ommaya reservoir which can be used for introduction of chemotherapy within 48-72 hours after placement
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00992602
Study Brief:
Protocol Section:
NCT00992602