Glioblastoma
Conditions
Interventions
Patients receive eribulin mesylate (1.4 mg/m2) intravenously once a week (q1w) on day 1 and day 8, and do not receive the drug on day 15. Courses repeat every 21 days in the absence of disease progres
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and gliosarcoma). 2) Evidence of progression or recurrence of glioblastoma confirmed on contrast-enhanced MRI within 14 days prior to enrollment. CT with or without contrast enhancement and MRI without contrast enhancement are not allowed. Presence of a measurable lesion is not required. 3) Corticosteroid dose must be stable or decreasing for at least 7 days prior to the contrast-enhanced MRI described in 2). 4) No episode of intracranial (including intratumoral) hemorrhage for 28 days prior to enrollment. 5) No evidence of tumors in the cerebellum, brain stem, pituitary gland, optic nerve and olfactory nerve, and no evidence of meningeal dissemination. 6) Prior treatment with postoperative temozolomide concomitantly with radiotherapy and at least for two cycles (5/28d) as an adjuvant treatment at newly-diagnosed setting. 7) History of bevacizumab treatment. 8) No history of eribulin treatment. 9) More than 180 days after initiation of temozolomide concomitant with radiation therapy have past at enrollment. 10) More than 90 days after completion of radiotherapy have past at enrollment. For patients who underwent reoperation, more than 14 days have past postoperatively at enrollment. 11) More than 28 days after completion of any other chemotherapeutic treatment including bevacizumab have past at enrollment. 12) Age between 20 and 75 years at enrollment. 13) KPS >= 70 within 14 days prior to enrolment. 14) Adequate organ and bone marrow function as defined below. All screening labs should be performed within 14 days prior to enrollment and G-CSF administration is not allowed in this period: i) absolute neutrophil count >= 1,500/mm3 ii) platelets >= 100,000/mcL iii) hemoglobin >= 9.0 g/dL iv) AST <= 100 U/L v) ALT <= 100 U/L vi) creatinine <= 1.5mg/dL 15) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) History of malignancy except for malignant glioma for at least 2 years prior to enrollment (those who had adequately treated carcinoma in situ, intramucosal carcinoma or equivalent malignancy can be enrolled). 2) Active infection requiring systemic therapy. 3) Body temperature >= 38 degrees Celsius at enrollment. 4) Clinical or radiographic evidence of interstitial pneumonia or pulmonary fibrosis at enrollment. 5) Positive HIV antibody, HBs antigen or HCV antibody (however, those who are positive for HCV antibody but negative for HCV-RNA detection can be enrolled). 6) Negative HBs antigen but positive HBs or HBc antibody, and positive HBV-DNA detection (those who are negative for HBV-DNA detection can be enrolled). HBV-DNA test is not necessary for those who are positive for HBs antibody only (including medical workers). 7) Women during pregnancy, possible pregnancy or breastfeeding 8) Uncontrolled diabetes mellitus. 9) Clinically significant heart dysfunction, or history of heart dysfunction. 10) Psychosis or with psychotic symptoms that disturb regular daily life and prevent trial participation. 11) Allergy or any reason to prohibit the use of contrast enhancement agent for MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Progression-free survival (PFS), Response rate, QOL, safety | — |
Countries
Japan
Contacts
Public ContactMasamichi Takahashi
National Cancer Center Hospital Department of Neurosurgery and Neuro-Oncology
Outcome results
None listed