Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00805376 : Delta-24-RGD for Recurrent Malignant Gliomas
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients with histologically proven recurrent malignant primary glioma will be
eligible. Glioma type will be restricted to: GBM, gliosarcoma (GS), anaplastic
gliomas [anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic
infiltrating glioma (AIG), mixed anaplastic glioma (MAG), anaplastic ependymoma]

2. Patients must show unequivocal evidence for tumor recurrence or progression by MRI
scan within 15 days prior to Day 0/Baseline procedure after failing prior surgical
resection, biopsy, chemotherapy or radiation

3. For patients entered in Group A (see Treatment Plan) tumors must be accessible for
stereotactic injection. Tumors must be between 1.0 - 5.0 cm in diameter

4. For patients entered in Group B (see Treatment Plan) tumors must be surgically
resectable, and surgical resection must be indicated at the time of baseline
evaluation. Tumors must be >1.0 cm in diameter.

5. Patients will consent to have a biopsy taken at the time of the stereotactic
injection to confirm the presence of malignant glioma (based on frozen section)
before injection of Delta-24-RGD-4C

6. For each patient there must be a consensus between the physician investigators in
this study that injection will not deliver Delta-24-RGD-4C into the ventricular
system. Patients must have a stable steroid regimen for at least 1 week prior to
Delta-24-RGD-4C administration

7. Patients may or may not have had prior chemotherapy

8. Patients must be willing and able to give informed consent

9. Age > /= 18 years

10. Patients must have a Karnofsky performance status >/= 70

11. Patients must have recovered from the toxic effects of prior therapy (i.e., CTC grade
1 or less). For example, they must be at least two weeks after vincristine, 6 weeks
after nitrosoureas, and 3 weeks after procarbazine or temozolomide administration

12. Patients must have adequate bone marrow function (absolute granulocyte count > 1,500
and platelet count of > 100,000), adequate liver function (SGPT and alkaline
phosphatase < 2 times institutional normals and bilirubin <1.5 mg%), and adequate
renal function (BUN or creatinine <1.5 times institutional normal) prior to starting
therapy

13. This study was designed to include women and minorities, but was not designed to
measure differences of intervention effects. Males and females will be recruited with
no preference to gender

14. No exclusion to this study will be based on race. Minorities will actively be
recruited to participate. The malignant glioma patient population treated at MDACC
over the past year is as follows: American Indian or Alaskan Native - 0, Asian or
Pacific Islander - <2%, Black, not of Hispanic Origin - 3%, Hispanic - 6%, White, not
of Hispanic Origin - 88%, Other or Unknown - 2%, Total - 100%

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 (B
or C) or HIV seropositivity

8. Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the
retinoblastoma gene or its related pathways

9. Multiple intracranial malignant glioma lesions at the time of recurrence. Multiple
enhancing areas within a single tumor will not be considered multiple 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. Current diagnosis of other cancer except curative cervical cancer in situ, basal or
squamous cell carcinoma of the skin. Patients with a history of another cancer, but
who are cancer free for a minimum of three years remain eligible

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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00805376      |      Link to official Clinicaltrials.gov listing
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