Gene Therapy for Meningeal Carcinomatosis 
6. 1 1 Management of Specific Toxicities 
Management of potential chemical meningitis from injection of the vector-producer cells 
into the subarachnoid space has been discussed in section 3.32 and consists primarily of 
symptomatic relief with analgesics or steroid therapy combined with surveillance for potential 
infection. Management of other specific toxicities were previously discussed. (See 3.3) 
6.2 Symptomatic Therapy for Toxicity 
Symptomatic therapy such as analgesics or other helpful therapy may be administered if 
deemed necessary by the participating investigators. All medications administered will be recorded 
in the appropriate Case Report Form. 
7.0 Criteria for Discontinuation of Study Patients 
7.1 Criteria for Treatment Discontinuation 
Participation in this study can be discontinued for any of the following reasons: 
o At the Patient's request: Any patient who wishes to withdraw from the study may do so but 
will be counseled that long-term follow-up for the effects of gene therapy are strongly desired by 
the medical facility and federal regulatory groups. 
o A major, unexpected, or life-threatening toxicity requiring that treatment be discontinued 
o Generalized impairment or mental incompetence which would render the patient unable to 
understand his/her participation in the study. In such cases continuation will be determined by the 
person designated by durable power of attorney. 
o If, in the Investigator's medical judgment, further participation would be injurious to the 
subject's health or well-being. 
o Administrative reasons, such as subject non-compliance or a major protocol violation, 
o Pregnancy 
An explanation will be recorded for any patient that is taken off treatment and the appropriate Case 
Report Form completed . 
7.2 Criteria for Study Discontinuation 
Patients should understand that once they have completed (at least one cycle of therapy), 
they will be asked to be followed long-term. They can stop study treatment at any time (see section 
7.1), however they will still be considered on study until the study has been terminated. 
8.0 Adverse Experiences 
Appendix VII is Adverse Experience Reporting 
Depending on the extent of the adverse experience, adverse events will be reported to the 
NIH Institutional Review Board (IRB), Institutional BioSafety Committee (IBC) and to Genetic 
Therapy, Inc. (sponsoring company) as specified in Appendix VII. 
Adverse reactions or deaths requiring immediate reporting will be made by telephone to 
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