recurrent glioma at brainstem
Conditions
Interventions
Nimustine hydrochloride, will be started. 7 ml Nimustine hydrochloride at concentration of 0.75 mg/ml, which is a predefined maximum tolerable concentration from preceding Phase I study, will be used
200mg/m2 daily for 5 days.
Sponsors
Tohoku University
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 radiation therapy. 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 (adult<1.5 mg/dl, pediatric<2 x upper limitation of corresponding age and sex) should be cleared 5) Informed consent taken from the patient. In case 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) Women in pregnancy 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 (adult >1.5 mg/dl, pediatric > 2 x upper limitation of corresponding age and sex) 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 3.5 months survival rate for pediatric cases and 6 months survival for adult cases | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Response rate, and Adverse events | — |
Countries
Japan
Contacts
Public ContactRyuta Saito
Tohoku University Hospital Department of Neurosurgery
Outcome results
None listed