CLINICAL TRIAL SUMMARY

MDACC Study No:ID01-310 (clinicaltrials.gov NCT No: NCT00805376)
Title:Phase I Trial of Conditionally
Replication-Competent Adenovirus (DNX-2401)
for Recurrent Malignant Gliomas
Principal Investigator:Frederick F. Lang
Treatment Agent:DNX-2401
Study Status:Open
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of DNX-2401 that can be injected directly into brain tumors and into the
surrounding brain tissue where tumor cells can multiply. A second goal is to
study how the new drug DNX-2401 affects brain tumor cells and the body in
general.

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Disease Group:Brain; CNS
Phase of Study:Phase I
Treatment Agents:DNX-2401
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:1-2 days for both groups for injection of DNX-2401 and another 3-5 days after
resection of the tumor (Group B)
Supported By:N/A
Return Visit:Grp A: Day 4, 7, 14, 28, mo 2, 3, 4, then Q 8 wks for 2 yrs, then Q 24 wks
Grp B: Day 4, 7, 13. 15, 18, 21, 28, 42, mo 2, 3, 4, then Q 8 wks for 2 yrs,
then Q 24 wks
Grp B (Stage 2): Day 4, 7, 14, 28, mo 2, 3, 4, then Q 8 wks for 2 yrs, then Q
24 wks
Home Care:Patients in Group B will be sent home with the injection catheter in place
(under the skin) for 2 weeks.


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Physician Name:Frederick F. Lang
Dept:Neurosurgery
For Clinical Trial Enrollment:713-563-2883
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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