3. Partial responders: 
Patients with greater than 50% decrease in fluid volume as measured by abdominal girth changes 
or reduction in effusion volume and a greater than 50% reduction in malignant cells within the fluid. Also 
includes patients who reabsorb fluid but have reaccumulation of fluid to the original volume within 30 
days. 
4. Complete responders: 
No residual malignant effusion. 
E. Re- treatment Criteria 
In the event of a significant clinical response, individual patients would be retreated following a similar 
protocol. 
F. Off-treatment Criteria 
We do not intend to retreat patients unless indicated as in II. E. 
III. Data monitoring 
The investigators will allow the FDA or other government representatives to inspect study 
documents including consent forms and hospital charts. Adverse drug reactions to the infused retroviral 
stock will be reported promptly to the FDA, Vanderbilt IRB, and Vanderbilt IBC even if there is only a 
suspicion of a drug effect. Life threatening reactions will be reported by phone within 24 hours with 
written report within 10 working days. Any revisions to the protocol will be discussed between 
investigators, the FDA, and others as required prior to submitting formal changes to the IRB and FDA. 
5. Risks of the study 
The potential risks of this study are listed below: 
Risk of MRI and CT scans: injury due to movement of metal clips or foreign bodies 
Risk of Blood drawing (Phlebotomy): hematoma, bleeding 
Risk of paracentesis, thoracentesis, or lumbar puncture: hemorrhage, viscus perforation, infection. 
Removal or infusion of fluid can result in allergic reaction, fluid imbalance, heart failure, or 
electrolyte abnormalities 
Risk of retroviral gene therapy: Although the retroviral vectors employed in this trial are unable to 
reproduce or replicate, since they are an untested form of cancer treatment, unknown or uncommon 
side effects may occur. Unsuspected infectious agents could be introduced during infusion of 
retroviral vector. 
Additional risks: Possible risks of the study include an allergic reaction to the media or the retroviral 
vector; and the possibility of tumor necrosis what could produce local immune responses and 
systemic effects such as uric acid elevation. 
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