Phase II trial of eribulin in patients with recurrent glioblastoma (ENIGMA)
- Conditions
- Glioblastoma
- Registration Number
- JPRN-UMIN000030359
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One-year survival rate
- Secondary Outcome Measures
Name Time Method Overall survival (OS), Progression-free survival (PFS), Response rate, QOL, safety