12.2 Enter all patients by phoning Dr Heslop Dr Krance or Dr Brenner. The 
following forms should be completed: 
On study form 
Investigational agents flow sheet forms 
Off study forms 
12.3 Adverse reactions will be reported by phone to Drs Heslop, Krance or Brenner 
within 24 hours of their occurrence. These adverse reaction reports include all 
life-threatening events (Grade 3/4 toxicity) and all fatal events. 
13.0 INFORMED CONSENT 
All patents and/or their legal guardian must sign a document of informed consent 
consistent with local institutional and Federal guidelines stating that they are aware of the 
investigational nature of this protocol and of the possible side effects of treatment. 
Further, patients must be informed that no efficacy of this therapy is guaranteed, and that 
unforeseen toxicities may occur. Patients have the right to withdraw from this protocol 
at any time. No patient will be accepted for treatment without such a document signed 
by him or his legal guardian. Full confidentiality of patients and patient records will be 
provided according to institutional guidelines. 
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Recombinant DNA Research, Volume 19 
