Malignant Glioma
Conditions
Interventions
Case series:Valganciclovir table QD+PD-1 inhitor IV Q3W
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
5 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Both sexual, be willing and able to provide written informed consent/assent for the trial. Be >/= 18 years of age on day of signing informed consent, 5 to 18 years of age signing informed consent by parents; 2. Have histologically confirmed World Health Organization Grade IV malignant glioma (glioblastoma or gliosarcoma). Participants will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of glioblastoma or variants is made; 3. Patients must be at first or second relapse and clinically require reoperation for tumor progression within 4 to 6 weeks. Note: Relapse is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation+ chemotherapy). If the participant had a surgical resection for relapsed disease and no antitumor therapy instituted for up to 12 weeks, this is considered one relapse. For participants who had prior therapy for a low grade glioma, the surgical diagnosis of a high grade glioma will be considered first relapse; 4. Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Have viral inclusion bodies in tumor tissue, or HCMV antibody detection of IgG and IgG positive or HCMV-PP65 antigen positive, or HCMV- fluorescent PCR positive in tumor tissue; 5. High expression of PD-L1 in tumor tissue, and tumor infiltrating lymphocytes consider as drug specifically targeting T-cell co-stimulation or checkpoint pathways; 6. Have a performance status of >/= 60 on the Karnofsky Performance Scale (KPS); 7. Have measurable disease consisting of a miaxmal volume of 3 cm^3; 8. Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day; 9. Demonstrate adequate organ function as defined in additional table 1, all screening labs should be performed within 14 days prior to registration; (1) Hematological: Absolute neutrophil count (ANC) >/=1,500 /mcL; Platelets >/=100,000 / mcL; Hemoglobin >/= 9 g/dL or >/= 5.6 mmol/L; (2) Renal: Serum creatinine /= 60 mL/min for subject with creatinine levels > 1.5 * institutional ULN; 10. Hepatic: Serum total bilirubin 1.5 ULN; AST (SGOT) and ALT (SGPT) </= 2.5 * ULN OR </= 5 * ULN for subjects with liver metastases. 4) Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) </= 1.5 * ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time (aPTT) </= 1.5 * ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; 11. Female subject of childbearing potential should have a negative serum pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Patients with pathologic diagnosis was not clear and refused again surgery to obtain the tumor tissue samples; 2. Has been treated previously with bevacizumab; 3. Has tumor localized primarily to the brainstem or spinal cord; 4. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery; 5. Participating or has participated in a study of an investigational agent or using an investigational device, in 4 weeks since last dose of agent administration; 6. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 2 mg of dexamethasone total per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial; 7. Pneumonia or pulmonary interstitial inflammation. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Testing not required. Has known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Inoculation of live vaccine within 30 days; 8. Has an active infection requiring systemic therapy; 9. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; 10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| partial or complete remission rate;Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life; | — |
Contacts
Public ContactQiu Yongming
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed