initially diagnosed pediatric diffuse intrinsic pontine glioma (DIPG), adult brainstem glioma Malignancy
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
150 mg/m2 daily for 5 days.
Sponsors
Tominaga Teiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) MRI had to demonstrate that at least two-thirds of the tumor was situated in the pons and that the origin of the tumor was clearly within the pons. 2) Initially diagnosed patients with 3-21 years of age. 3) 28-35 days interval from prior radiation and/or chemotherapy. 56 days interval may be allowed for patients who got re-registered to the study. 4) Patients received no prior anti-tumor treatment except radiation and temozolomide chemotherapy. 5) KPS>=50 at screening. 6) Patients expected to be alive for more than 2 months. 7) Appropriate systemic condition: WBC(>=3,000/mm3), Hb(>=8.0 g/dl), Plt(>=100000/mm3), AST( Initially diagnosed adult patients who fulfill #1, 3, 4, 5, 6, 7, 8 of the pediatric criteria. Recurrent adult patients who fulfill below mentioned #9 and 10 in addition to #1, 5, 6, 7, 8 of the pediatric criteria. 9) Patients with tumor enlargement or symptom deterioration after standard radiation therapy. 10) More than 28 days interval from prior anti-tumor treatment.
Exclusion criteria
Exclusion criteria: 1) Co-existence of uncured cancer. 2) Patients with brain / spinal cord dissemination. 3) Women in pregnancy or possibly pregnant women or breast feeding women. 4) Patients who cannot take appropriate methods for contraception. 5) Infected patients who require systemic antibacterial or antiviral therapy. 6) Patients with hemorrhagic diathesis. 7) Patients taking anti-coagulants or anti-platelet agents within 21 days before clinical trials registry. 8) HBs antigen-positive patients. 9) Existence of mental disorder that makes participation to this study difficult. 10) Poor control of diabetes mellitus. 11) Patients who cannot undergo examinations or treatments required in this study. 12) Past history of pulmonary fibrosis or interstitial pneumoniae. 13) Patients with contraindication to MRI with contrast enhancement using gadolinium. 14) Patients with hypersensitivity to Nimustine hydrochloride (ACNU). 15) Patients participating in any other clinical trial. 16) Patients who should not be recruited to the clinical trial as determined by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year survival rate of pediatric DIPG cases | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival of pediatric cases Response rate for pediatric cases [Exploratory endpoints] Overall survival for adult cases Response rate for adult cases | — |
Contacts
Public ContactAya Sato
Tohoku University Hospital
Outcome results
None listed