Recurrent Glioblastoma Multiforme MedDRA version: 9.1 Level: LLT Classification code 10018337 Term: Glioblastoma multiforme
Conditions
Interventions
Product Name: Delta-24-RGD Adenovirus
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Delta-24-RGD
Current Sponsor code: Delta-24-RGD, Ad5-Delta24RGD
Other descriptive
Sponsors
VU Cancer Centre, Afdeling Geneeskundige Oncologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven primary Glioblastoma Multiforme (GBM) will be eligible for this protocol. 2. Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan within 3 weeks prior to registration after failing prior resection (surgical or biopsy) and radiation- and or chemotherapy. 3. Recurring tumors must either be accessible for surgery, or, when not accessible for surgery meet the following criteria: - unifocal - midline shift = 0.5 cm - no radiological signs of uncal herniation 4. All recurring tumors must be restricted to one hemisphere, without signs of subependymal spreading. 5. Before start of virus treatment histological analysis of the resected, or biopsied tumor recurrence must confirm the diagnosis of GBM (based on frozen section). 6. Patients may or may not have had prior chemotherapy. 7. Patients must be able to read and understand the informed consent document and must sign and date the informed consent. Procedures to obtain such informed consent should be according to ICH-GCP, the local regulatory requirement and the rules followed at the institute. 8. Patients must be > 16 and 70 % (Appendix 2 of the protocol). 10. Patients must have recovered from the toxic effects of prior therapy. For example, they must be at least two weeks after vincristine, 6 weeks after nitrosoureas, 3 weeks after procarbazine or temozolamide administration, and 6 weeks after radiation therapy. 11. If sexually active, patients must be willing to use barrier contraception for the duration of the study. 12. Patients must have adequate hepatic, renal and bone marrow function, defined as • absolute neutrophil count (ANC) > 1,5* 109/L • platelet count of > 100* 109/L • ALT (SGPT), AST (SGOT) and Alkaline Phosphatase = 2 times ULN • total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with active uncontrolled infection, signs of active viral infection, upper pulmonary infection and flu-like signs. Patients with presence of adenovirus in pre-treatment throat-swab sample or serum as detected by PCR assay. All patients must be afebrile (<38.0°C) at the start of therapy. 2. Evidence of bleeding diathesis or use of anticoagulant medication. 3. Patients with systemic diseases or other unstable conditions which may be associated with unacceptable anesthetic/ operative risk and/or which would not allow safe completion of this study protocol, e.g. uncontrolled seizures, steroid dependence. 4. Because of the potential risk of a recombinant virus containing a gene involved in cellular growth regulation and differentiation which could potentially affect a developing fetus or growing infant, females who are pregnant, at risk of pregnancy, or breast feeding a baby during the study period are excluded. 5. Because of the potential risk of serious infection in immune-compromised individuals, patients with HIV infection are excluded. 6. Patients with a known germline deficit in the retinoblastoma gene or its related pathways. 7. Patients with other primary malignancy than GBM. However, patients with curatively treated carcinoma-in situ or basal cell carcinoma or patients who have been disease-free for at least 2 years and not using any anti-cancer therapy, are eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability (defined as the Maximum Tolerated Dose (MTD)) of Delta-24-RGD Adenovirus administered by Convection Enhanced Delivery (CED) to the tumor and the surrounding infiltrated brain in patients with recurrent Glioblastoma Multiforme.;Secondary Objective: To determine the Progression Free Survival (PFS), Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable for surgical resection and treated at the MTD.;Primary end point(s): The primary endpoints of this study are: - To determine the Maximum Tolerated Dose - To evaluate the safety of the study treatment | — |
Countries
Netherlands
Outcome results
None listed