9.2 Autopsy Studies 
Autopsies will be performed on all patients as a final assessment of any 
local or systemic toxicity. At autopsy, the skin of the injection sites will 
be visibly examined, and if any gross lesions are detected, these sites will 
be sampled for histology. The remaining, non-resected kidney will be 
thoroughly sampled to rule out that autoimmune renal disease is induced by the 
renal antigens administered in the renal carcinoma vaccine. All other organs 
in the body will be thoroughly sampled (per Johns Hopkins Pathology Department 
routine) to both assess any possible systemic toxicity and to establish 
proximate and contributing causes of death. Autopsies will be performed by 
the Pathology housestaff per hospital protocol routine under the supervision 
of a faculty preceptor and the chief study pathologist, Dr. Audrey Lazenby. 
If the patient dies outside of the Johns Hopkins Hospital, the body will be 
transported by the decedent's funeral home to Hopkins. Transportation and 
autopsy will be performed as above at no cost to the patient's family. 
9.3 Management of Toxicities 
9. 3. a. Local Toxicities: 
Tissue destructive toxicities will be evaluated by the Johns 
Hopkins Dermatology and Plastic Surgery consultation services. Skin care 
will follow standard practice based on diagnostic testing. If clinically 
appropriate, in the event of purulent discharge from vaccine sites, cutaneous 
and sterile saline subcutaneous aspirates for gram stain and culture and 
antibiotic sensitivity will be obtained to evaluate cellulitis versus GM-CSF 
induced neutrophilia. 
9.3. b. Systemic Toxicities 
Fever and chills. All patients will be examined and blood 
cultured, as well as further evaluated as clinically indicated for fever > 
101°F . Fevers may be managed with acetaminophen 650mg po q 4-6 hr. As these 
patients are uninephric, all non-steroidals and aspirin derivatives will be 
strictly contra-indicated at all times. 
Headache. May be managed by acetaminophen/650 mg po q4h 
Nausea, vomiting. May be managed with diphenhydramine 
(25-50 mg IV). Decadron is strictly contraindicated. 
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