Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1) (NCT06193174) | Clinical Trial Compass
TerminatedPhase 1
Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1)
Stopped: Not enough eligible participants to enroll.
United States1 participantsStarted 2024-06-21
Plain-language summary
The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when re-administered into the brain where the tumor is located.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Patients must have histologically or cytologically confirmed recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
Prior therapy. Patients must have failed a course of external beam radiotherapy to the brain at least 4 weeks prior to enrollment.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of C134 in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
Karnofsky Performance Status ≥70%
Life expectancy of greater than 4 weeks.
Patients must have normal organ and marrow function as defined below:
leukocytes \>3,000/ μl absolute neutrophil count \>1,500/ μl platelets \>100,000/ μl total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal Creatinine within normal institutional limits OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Residual lesion must be ≥1.0 cm in diameter as determined by MRI.
The effects of C134 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the first six months after receiving C134. Because it is currently unknown if C134 can be transmitted by sexual contact, a barrier method of birth control should be employed. Should a woman become p…