Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas (NCT02659800) | Clinical Trial Compass
TerminatedPhase 1
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
Stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
United States12 participantsStarted 2018-10-30
Plain-language summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed high grade glioma by pathology (World Health Organization \[WHO\] grade III and IV)
* Patients' post-operative treatment must have included at least 80% of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes \[TIL\], lymphokine-activated killer \[LAK\] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
* Patients must have CD4 =\< 300 cells/mm\^3 in the last week (7 days) of standard radiation + temozolomide treatment (58-60 Gy radiation with temozolomide 75 mg/m2 daily during radiation)
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 50,000/mcL (need to confirm before administering study drug)
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
* Creatinine =\< institutional upper limit of normal OR creatinine clearance \>= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Activated partial t…
What they're measuring
1
Absolute total CD4 cell counts
Timeframe: At 6 weeks (after standard radiation and temozolomide treatment completion)
Trial details
NCT IDNCT02659800
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins