The laboratory evaluation of retroviral insertion will be the responsibility of Drs. 
Furman and Brenner. 
12.0 REPORTING REQUIREMENTS 
12.1 Register all patients with Bone Marrow Transplant Data Manager at Ext 410. 
12.2 Enter all patients by phoning Dr. Furman 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 Dr. Furman or Dr. Brenner 
within 24 hours of their occurrence. These adverse reaction reports include all 
life-threatening events (Grade 3/4 toxicity, Section 9.0) which may be due to 
tumor cell injection, 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 unforseen 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. 
See attached document of informed consent in section 17. 
Patients may be asked to volunteer for other appended or ancillary protocols which 
investigate other questions such as issues of supportive care, the use of hematopoietic 
growth factors, management of infectious diseases and/or their prophylaxis, and 
pharmacokinetic studies. Such protocols will not be implemented without the review 
and approval of the Institutional Review Board. In circumstances where such 
protocols are approved, a separate informed consent document, consistent with the 
above guidelines, will be obtained 
[ 760 ] 
Recombinant DNA Research, Volume 15 
