Status and phase
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Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18 years or older; male or female
Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible if histological assessment demonstrates transformation into GBM.
Cancer progression after treatment with the following: surgery, radiation therapy and temozolomide as first line treatment with no other therapy prior to tumor recurrence.
An interval of at least 12 weeks after last dose of radiation and temozolomide is required, unless cancer progression is proven by diagnostic tumor biopsy. If temozolomide is being used in a maintenance phase, there must be a 28-day washout period prior to Randomization.
Stable or decreasing dose of corticosteroids for at least 7 days prior to randomization.
Capable of providing informed consent and complying with trial procedures.
Karnofsky Performance Status 70 or above.
ECOG performance status 0-2.
Life expectancy 8 or more weeks.
Measurable tumor lesions according to RANO working Group Criteria.
a. In the case that there is "non-measurable" disease due to a radical surgical resection during screening, the subject still qualifies if Inclusion #3(b) is met.
Women must not be able to become pregnant for the duration of the study.
Women of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
Geographically accessible to site, i.e. the ability to come to the study site for each scheduled appointment and evaluation.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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