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SCCA Breast Cancer Clinical Trials

High-dose Methotrexate + Liposomal Cytarabine (6954)
A Phase II Study of the Combination of High-dose Methotrexate and Intrathecal Liposomal Cytarabine in Patients with Parenchymal and Leptomeningeal Metastases from Breast Cancer
Status Conditions Phase Study ID
Open Stage IV Breast Cancer
Central Nervous System Involvement/Metastases
Leptomeningeal Metastases
Recurrent Breast Cancer
Tumors Metastatic to Brain		 Phase II 6954
NCT00992602
Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate and liposomal cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose systemic methotrexate with intra-CSF liposomal cytarabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with CNS metastases from metastatic breast cancer.


Investigator
Maciej Mrugala, MD, PhD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

 

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Women 18 years or older who are not pregnant (contraception must be used throughout the study)
  • Diagnosis of breast cancer with metastases to CNS (regardless of receptor status)
  • Ability 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 index lesions (untreated) 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
  • Acceptable bone marrow function as documented by history and current complete blood counts (CBC): WBC > 3.0 K, ANC > 1.5 K, PLT > 100 K, HCT > 30 %
  • Acceptable renal function (GFR >= 60 mL/min)
  • Acceptable liver function (see exclusion criteria)
  • Well controlled systemic disease
  • Therapy for systemic disease allowing for addition of systemic HD-MTX and IT Depocyt (in general patients receiving trastuzumab or lapatinib at the time of enrolment will be allowed to continue)
  • Bisphosphonates (i.e., zolendronic acid) will be allowed
  • Mini-mental status examination score of 24 or above
  • Enzyme-inducing anti-seizure medications are allowed, however, when possible non-enzyme inducing drugs should be selected
  • In Her2/Neu positive patients, continuation of trastuzumab or lapatinib for systemic disease may continue at the discretion of the treating physician
  • Steroids are allowed
Last Updated
May 31, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.