This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with glioblastoma who have progressed following surgery and prior treatments.
This is a second line open-labeled pilot phase 2 study in subjects with glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and Temozolomide. Patients who have received avastin as a second-line treatment are not eligible for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
City of Hope National Medical Center
Duarte, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Ochsner Health System
New Orleans, Louisiana, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Objective Response Rate (Complete Response and Partial Response)
ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria. CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR. PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.
Time frame: up to 6 months
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