DRKS00022861
Completed
Phase 1
A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma - CUSP9v3
niversitätsklinikum Ulm, Kliniken am oberen Eselsberg0 sites10 target enrollmentAugust 13, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Glioblastoma
- Sponsor
- niversitätsklinikum Ulm, Kliniken am oberen Eselsberg
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a diagnosis of glioblastoma World Health Organization (WHO) grade IV (histologically confirmed by a pathologist). Patients with prior low\-grade glioma are eligible if histological transformation to WHO grade IV glioblastoma was confirmed.
- •Progression (according to RANO criteria) after prior radiation and temozolomide treatment
- •No more than 3 prior episodes of tumor progression
- •\= 4 weeks between surgical resection or chemotherapy
- •\= 12 weeks since last radiotherapy
- •Patients \> 18 years of age.
- •Karnofsky performance status (KPS) of \= 70%
- •Stable steroid dose for \= 1 week
- •Hemoglobin \= 10 g/l
- •Absolute neutrophil count (ANC) \> 10³ cells/µl
Exclusion Criteria
- •Female patients who are pregnant or breast\-feeding
- •Any uncontrolled/unstable medical condition except glioblastoma, including but not limited to uncontrolled/unstable hypertension, uncontrolled/unstable diabetes, uncontrolled endocrinopathies of any kind, uncontrolled/unstable psychiatric conditions
- •Renal failure (eGFR \< 60 ml/min)
- •Active infection, including pneumonia as shown on X\-ray
- •Therapeutic anticoagulation use
- •Prior stereotactic radiosurgery
- •Radiation implants
- •Radiolabeled monoclonal antibody therapy unless there was unequivocal disease progression (e.g. a new lesion or biopsy\-confirmed recurrence)
- •QT interval (QTc) \< 470 msec (based on the mean value of triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome, or known history of QTc prolongation or Torsade de Pointes
- •Uncontrolled electrolyte disorders that can aggravate the effects of a QTc\-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
Outcomes
Primary Outcomes
Not specified
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