The primary purpose of this study is to test the safety of Pembrolizumab and Temozolomide in treating recurrent glioblastoma and to characterize the effect of this treatment on the participants tumor and immune system..
Participants will undergo screening tests to determine if they are eligible to participate. This will involve a complete history and physical examination, vital signs, blood tests including complete blood count (CBC), and serum chemistry (CMP). Participants will receive one cycle of Temozolomide and Pembrolizumab prior to removing recurrent tumor, followed by three weekly cycles of treatment until progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Characterize the safety and immunologic/genomic/metabolomic effects of neoadjuvant Pembrolizumab and Temozolomide in recurrent glioblastoma.
James Graham Brown Cancer Ctr.
Louisville, Kentucky, United States
RECRUITINGTreatment toxicity
Quantification of the frequency of adverse events in patients treated with neoadjuvant Pembrolizumab and Temozolomide with gross total resection of recurrent glioblastoma.
Time frame: Change in frequency of adverse events prior to gross total resection or recurrent glioblastoma
Overall Survival
Progression and response to treatment will be determined using the Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: Every 8 weeks for 24 months
Neurologic function and quality of life
Using the Neurologic Assessment in Neuro-oncology (NANO) scale on each visit. In addition, the Eastern Cooperative Oncology Group (ECOG) performance status will be monitored.
Time frame: Every 8 weeks for 24 months
Treatment Toxicity
Quantification of the frequency of adverse events in patients treated with neoadjuvant Pembrolizumab and Temozolomide after gross total resection of recurrent glioblastoma.
Time frame: Change in frequency of adverse events after gross total resection or recurrent glioblastoma
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