follow-up tests, they may be used for research purposes including the growing of additional 
neuroblastoma cells in the laboratory, unless indicated otherwise. 
Potential Risks 
Administration of tumor cells genetically engineered to express interferon has never been 
studied in humans before and may have unknown side effects. These include damage to 
normal tissues in the area of administration. Problems which arise are likely to be reversible 
when the treatment is stopped but occasionally can persist and may cause serious subsequent 
complications. The following kinds of side effects could be observed with this treatment 
program: 
1 . Allergic reactions such as rash, skin tenderness, swelling, fever and or hives. More severe 
allergic reactions including shortness of breath, a drop in blood pressure and or fainting 
could also be possible. 
2. Pain, bruising and or infection may occur at the injection sites. Granuloma formation 
(development of hard lump) at the injection site could occur. The granuloma could become 
hardened, red and irritated and could require a skin incision to drain it by my (my 
child/ward's) physician. It could be present as long as I (my child/ward) continue to 
receive tumor cell injections, but should likely resolve within several weeks of stopping 
treatment. 
3 . I (my child/ward) could experience general malaise, lethargy, joint pains and/or fever. The 
treatment could also cause my (my child/ward's) immune system to attack tissues within 
my (my child/ward's) body. Such immune attack is known as an autoimmune reaction. 
This could result in symptoms such as rashes, sores in the mouth, fever, joint pains, 
enlargements of lymph glands, abnormalities of kidney function and or liver function, and 
potentially in abnormalities of the nervous system which are presently unknown. 
4. There is a small possibility that the tumor cell preparation could harbor a virus which might 
cause a second cancer to develop in me (my child/ward). This cancer would likely be a 
different cancer from the neuroblastoma. Precautions are taken to avoid transfer of viruses 
that might be likely to result in a second cancer, but it is not possible to completely insure 
against the possible transfer of viruses. Although highly unlikely, it is also theoretically 
possible that tumor cells from the treatment might themselves survive in the body and form 
a tumor. They have been treated with x-rays to prevent this. 
Recombinant DNA Research, Volume 19 
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