| Exclusion Criteria: | 1) Any radiotherapy within 4 weeks prior to date of Delta-24-RGD administration.
2) Active uncontrolled infection or severe intercurrent medical conditions. All patients must be afebrile at baseline (i.e., < 38.0 Celsius [C])
3) Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued , based on the clinical judgment of the surgeon, prior to Delta-24-RGD-4C injection then patient may be eligible.
4) History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems
5) Female who is pregnant and/or nursing. 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
6) Tumor position that, in the Investigator's opinion, would pose the risk of penetration of the cerebral ventricular system during injection with study drug. If, during the Delta-24-RGD-4C injection procedure, penetration of the ventricular system is suspected or confirmed, Delta-24-RGD-4C administration will be aborted
7) Immunocompromised subjects, subjects with autoimmune conditions, active hepatitis (A, B, C or D [Delta]) or HIV seropositivity
8) Patients with Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways
9) Multiple intracranial malignant glioma lesions
10) Tumor involvement which would require ventricular, brainstem or posterior fossa injection or access through a ventricle in order to deliver the virus
11) Tumor involving the subependyma or suspected cerebrospinal fluid (CSF) dissemination
12) Documented extracranial metastasis
13) Biologic/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks of Delta-24-RGD-4C administration
14) Concurrent chemotherapy, radiation or biological therapy
15) Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc.
16) White blood cell (WBC) < 2.5 x 103/mm3, absolute neutrophil count (ANC) < 1.5 x 103/mm3, platelet < 100,000/mm3, hemoglobin (Hgb) < 10.0 gm/dL, prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) > 1.8 x control
17) Grade 4 hematological toxicity
18) Serum creatinine > 1.5 mg/dL
19) Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) or total bilirubin > 2x the upper limits of normal
20) Vaccinations of any kind within 30 days prior to Delta-24-RGD-4C administration
21) History or current diagnosis of other cancer except curative cervical cancer in situ, basal or squamous cell carcinoma of the skin
22) History of encephalitis, multiple sclerosis, other CNS infection or primary CNS disease that would interfere with subject evaluation
23) Patients with history of prior gene transfer therapy or prior therapy with cytolytic virus of any type, especially Delta-24-RGD-4C
24) Males or females who refuse to use a double-barrier form of birth control during the study and for up to 6 months after injection with Delta-24-RGD-4C |