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A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who have GBM that has recurred or progressed following prior radiation therapy and TMZ.
Full description
This protocol describes a prospective single-center Phase 0/1 open-label study to evaluate the safety and efficacy of a high-throughput drug sensitivity assay to predict targeted therapies for patients who have GBM that has recurred or progressed following prior radiation therapy and TMZ. The underlying hypothesis is that treatment of patients with up to 3 lead candidates identified from individualized CSC/ HTS assays will safely (1) delay disease progression, and (2) increase survival. There is an abundance of literature strongly supporting the importance of a regimen for targeting CSCs and preventing tumor recurrence, as an additional strategy to improve the overall prognosis of cancer patients.
Enrollment
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Inclusion criteria
Determined at pre-screening:
Determined at or around surgery, and prior to performing HTS:
Determined at or around tumor recurrence, and after completion of HTS:
• Disease progression following radiation and TMZ therapy (as defined by RANO criteria (45); Appendix 3). Unlimited relapses are allowed, provided the functional status and other eligibility criteria for enrollment are met
Determined at baseline:
Signed informed consent for CSC/HTS based therapy prior to initiation of any study-specific procedure or treatment. The patient or the patient's legal authorized representative must be able to provide written informed consent (ICF) and understand the potential risks and benefits from study enrollment and treatment
Patients must have a KPS rating of ≥70 (see Appendix 4: Karnofsky Performance Scale)
Patients must have recovered from the toxic effects of prior therapy to < Grade 2 toxicity per NCI CTCAE version 4 (Appendix 6) prior to Day 1 of Cycle 1. The minimum duration required between prior therapy and initiation of study drug treatment is as follows:
Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
Hemoglobin (Hgb)> 8 g/dL
Absolute Neutrophil Count (ANC) > 1,000/mm3
Platelet count > 100,000/mm3
Creatinine < 2 mg/dL
Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 3x upper limit of normal (ULN)
Patients of childbearing potential must agree to use an adequate method of contraception for the duration of the study, and for 90 days following discontinuation of study drugs
Females of childbearing potential must have a negative pregnancy test
Patients must be negative for HIV, Hepatitis B and C
Patients are cooperative and able to complete all the assessment procedures.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Central trial contact
Nathan Hansen; Tracie Granger
Data sourced from clinicaltrials.gov
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