recurrent glioma at brainstem
Conditions
Interventions
First 3 cases receive convection- enhanced delivery of 7ml solution (volume is fixed to 7 ml throughout the study) of 0.25 mg/ml nimustine hydrochloride (mixed with 1mM Gd-DOTA: this concentration wil
Sponsors
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cases diagnosed clinically as well as radiologically as recurrent glioma at brainstem will be recruited. Recurrent cases of diffuse brainstem glioma as well as recurrent cases of gliomas originating from surrounding structure, i.e. thalamus, cerebellum, etc, and infiltrating brainstem will be included. In the recurrent cases of glioma originating from surrounding structure, histological diagnosis of the initial tumor is necessary. Since the disease occupy brainstem region, histological diagnosis of brainstem lesion is not necessary. 2) Recurrent cases after treatment with standard regimen; radiation plus oral temozolomide. 3) At least 4 weeks interval from prior radiation and/or chemotherapy. 4) Appropriate systemic condition: WBC (>3,000/mm3), Hb (>8.0 g/dl), Plt (>10x104/mm3), GOT (<100 IU/l), GPT (<100 IU/l), Cre (<1.5 mg/dl) should be cleared (within 14days of study initiation) 5) Informed consent taken from the patient. If it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his approval.
Exclusion criteria
Exclusion criteria: 1) Co-existence of uncured cancer. 2) Co-existence of meningitis or pneumonia that require treatment. 3) Pregnant women or possibly pregnant women or breast feeding women 4) Existence of active inflammation (CRP>2.0) 5) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l) 6) Existence of bone marrow insufficiency: WBC(<3,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3) 7) Renal dysfunction: Cre (>1.5 mg/dl) 8) Existence of hemorrhagic diathesis 9) Patients taking anti-coagulants or anti-platelet agents. 10) Existence of mental disorder that makes participation to this study difficult. 11) Poor control of diabetes mellitus 12) Past history of acute myocardial infarction within 3 months or unstable angina. 13) Past history of pulmonary fibrosis or interstitial pneumoniae.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of maximum tolerable concentration of ACNU | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, 6 months survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactRyuta Saito
Tohoku University Graduate School of Medicine Department of Neurosurgery
Outcome results
None listed