Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (NCT02062827) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
United States29 participantsStarted 2013-11-25
Plain-language summary
To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
* Prior therapy: Patients must have failed external beam radiotherapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment. Prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment.
* Age ≥18 years (age of majority for clinical trials in Alabama). Because no dosing or adverse event data are currently available on the use of M032 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)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): \<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 and \< 5.5 cm in diameter without bilateral extension thro…