Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis
NCT ID: NCT01373710
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2011-05-19
2018-04-09
Brief Summary
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Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL) near the conventional therapeutic concentration and depending on the dose-limiting toxicity (DLT)
Phase II: Determination of antitumor activity trastuzumab when administrated by IT or intra-ventricular in terms of neurological progression-free survival at 2 months
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Detailed Description
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Recommended dose (RD will be used in Phase II) Toxicity during treatment Clinical response to specific neurologic symptoms Time to neurologic progression Biological response: CSF cellularity and protein concentration Radiological response: cerebrospinal meningitis and neuraxis RMI Impact on quality of life Impact on survival (overall survival, survival without neurological progression, progression-free survival) Pharmacokinetics: dose of trastuzumab in CSF and plasma FCGR3A Genetic status influence on efficacy trastuzumab in metastatic breast cancer
Phase II: Secondary Outcome Measures :
Toxicity during treatment Clinical response to specific neurologic symptoms Time to neurologic progression Biological response: CSF cellularity and protein concentration Radiological response: cerebrospinal meningitis and neuraxis MRI Impact on quality of life Impact on survival (overall survival, survival without neurological progression, progression-free survival) Pharmacokinetics: dose of trastuzumab in CSF and plasma (confirmation of phase I data with 5 patients) FCGR3A Genetic status influence on efficacy trastuzumab in metastatic breast cancer
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trastuzumab intrathecal
Trastuzumab
One injection per week during 8 weeks by lumbar puncture or Ommaya Reservoir. 4 levels of doses are expected from 30 mg to 150 mg
Interventions
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Trastuzumab
One injection per week during 8 weeks by lumbar puncture or Ommaya Reservoir. 4 levels of doses are expected from 30 mg to 150 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2 Overexpression by IHC and / or amplification (FISH and or ICHS)
* Positive diagnosis of neoplastic meningitis: positive CSF cytology (obtained within 28 days before inclusion) AND / OR clinical symptoms of neoplastic meningitis and aspect of tumoral meningitis on MRI
* Brain metastases are allowed without prior treatment, if they are asymptomatics and without engagement. In cases of symptomatic brain metastases, subjects could be included only if surgery and / or radiotherapy (stereotactic or in toto) were performed and if the cerebral metastatic localization allow IT or intra-ventricular treatment. The last radiotherapy session or the surgery must have been done 3 weeks before.
* Aged 18 years old or more
* Male and female
* Life expectancy more than 2 months
* Satisfactory Cardiac function: left ventricular ejection fraction (LVEF) determined by ultrasound scan or myocardial scintigraphy
* Adequate Biological functions 14 days before inclusion, according to the criteria below: Neutrophils \> 1.0 x 109/L, Hemoglobin \> 9.0 g/dL (+ transfusion if needed,Platelets \> 50 x 109/L,Bilirubin \< 3 x N, ALT \& AST \< 10 x N, Creatinine \< 2.0 mg/dL, Clearance \> 25 mL/min (Cockcroft and Gault formula), Prothrombin time \> 70 %, Kaolin cephalin coagulation time \< 1.5 x N.
* Women of childbearing potential, must take adequate birth control measure during the study period and must have a negative pregnancy test (BetaHCG serum)
* The subjects must perform all evaluations of pre-inclusion, as provided by the protocol
* Signed written inform consent
Exclusion Criteria
* Anti-coagulant effective dose treatment when trastuzumab administration by lumbar puncture
* Patient on Lapatinib (wash out\> 2 weeks from the date of first dose intrathecal trastuzumab)
* Known or suspected trastuzumab allergy
* Contraindications of trastuzumab administration, including cardiac diseases: LVEF \<laboratory lower limit of normal or any other heart condition which would expose the subject to an unreasonable risk if he were to participate in the study
* Severe toxicity unresolved or unstable related to another previous study restricted drug and / or a cancer treatment
* Ventriculoperitoneal or atrial shunting excepted if the valve could be turn off (on-off switch) and the patient can stand it during 6 h after each injection of trastuzumab
* Dementia, altered mental status or psychiatric condition that would prevent the subject to understand or give informed consent
* Pre-existing severe cerebrovascular disease, such as stroke in a major vessel, vasculitis in the central nervous system or malignant hypertension
* Uncontrolled infection
* Participation in a clinical study with an experimental molecule
* No affiliation to a Social insurance (beneficiary or assignee)
* Pregnant women, breastfeeding or of childbearing age not taking contraceptive
* Subject unable to make follow up schedule
* Persons deprived of liberty or under guardianship (including curators)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Centre Leon Berard
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Centre Oscar Lambret
OTHER
Centre Francois Baclesse
OTHER
Institut Bergonié
OTHER
University Hospital, Toulouse
OTHER
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
University Hospital, Grenoble
OTHER
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Maya Gutierrez, MD
Role: STUDY_DIRECTOR
Institut Curie - Hopital Rene Huguenin - Saint-Cloud - France
Locations
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François Baclesse Center
Caen, Calvados, France
Rene Huguenin Hospital
Saint-Cloud, Haut de Seine, France
Oscar Lambret Center
Lille, Nord, France
Léon Bérard Center
Lyon, Rhone, France
Institut Bergonié
Bordeaux, , France
CHU Grenoble
Grenoble, , France
Institut du Cancer de Montpellier
Montpellier, , France
Institut Univesitaire du Cancer de Toulouse
Toulouse, , France
Institut Curie - Claudius Regaud Hospital
Paris, Île-de-France Region, France
Pitie Salpetriere Hospital
Paris, Île-de-France Region, France
Countries
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References
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Bonneau C, Paintaud G, Tredan O, Dubot C, Desvignes C, Dieras V, Taillibert S, Tresca P, Turbiez I, Li J, Passot C, Mefti F, Mouret-Fourme E, Le Rhun E, Gutierrez M. Phase I feasibility study for intrathecal administration of trastuzumab in patients with HER2 positive breast carcinomatous meningitis. Eur J Cancer. 2018 May;95:75-84. doi: 10.1016/j.ejca.2018.02.032. Epub 2018 Apr 7.
Other Identifiers
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2009-017218-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
09/501/M
Identifier Type: -
Identifier Source: org_study_id
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