Status:
WITHDRAWN
BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to open the blood vessels around the brain and allow tumor-killing substances to be carried directly to the brai...
Detailed Description
OBJECTIVES: Primary * Determine the safety and toxicity associated with blood-brain barrier disruption comprising transfemoral mannitol followed by methotrexate and carboplatin with or without trast...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer metastatic to the central nervous system (as documented by brain biopsy, cytology \[analysis from cerebrospinal fluid\]) OR radiographic evidence of brain metastasis with a diagnosis of systemic breast cancer
- Patients must have stable or no systemic disease as determined by a CT scan of the chest, abdomen, and pelvis
- HER2-positive or -negative disease by fluorescent in situ hybridization (FISH) or immunohistochemistry
- Patients with HER2-positive disease and signs of intracranial herniation and/or spinal block may first undergo intraarterial chemotherapy off study (with carboplatin, methotrexate, and trastuzumab \[Herceptin®\] by the same routes used on study) until radiographically shown to be safe to undergo blood brain barrier disruption, at which point they may be enrolled in the study
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 6 weeks
- Hematocrit ≥ 25%
- WBC ≥ 2,500/mm³
- Absolute neutrophil count ≥ 1,200/mm³
- Platelet count ≥100,000/mm³
- Creatinine clearance ≥ 50 mL/min (eligible for full-dose methotrexate) (30-49 mL/min allowed for patients receiving reduced-dose methotrexate)
- Bilirubin ≤ 2.0 times upper limit of normal
- LVEF normal by echocardiogram or MUGA
- Adequate pulmonary and cardiac function to tolerate general anesthesia as determined by physical examination and history
- No New York Heart Association class III-IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known allergy to trastuzumab (HER2-positive patients), carboplatin, methotrexate, or sodium thiosulfate
- No hepatitis B or C positivity
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection (e.g., HIV)
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- Prior surgery or biopsy allowed
- Prior chemotherapy and radiation therapy for metastatic breast cancer allowed
- No radiation or cytotoxic chemotherapy within the past 4 weeks (except trastuzumab or hormone therapy that has been part of the patient's ongoing treatment \[e.g., aromatase inhibitors for estrogen receptor positive patients\])
- No noncytotoxic regimens (e.g., targeted oral agents) within the past 2 weeks
- No investigational agents within the past 4 weeks
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00397501
Start Date
October 1 2013
End Date
October 1 2013
Last Update
April 21 2017
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