In addition to notifying the appropriate Federal and Group or Drug Company monitors, 
the University of Michigan Medical Center and the VA Medical Center both have internal 
notification procedures to follow. A copy of the completed form will be sent to the following 
groups: Nursing, Pharmacy, IRB Committee and appropriate medical staff. 
If the "ADR" is an unknown reaction which has not been previously reported for the 
drug in question, the consent form will also be modified to include the previously-unknown 
toxicity. If this is necessary, the modified consent will be submitted immediately to the IRB 
Committee. 
If the protocol in question is sponsored by the Cancer Center or one of the programs 
within the Cancer Center, the Protocol/Data Management section of the Clinical Trials Office 
will carry out the appropriate procedures for the "ADR" notification to both federal and 
hospital departments. 
12.0 BIBLIOGRAPHY 
1. Aebersold P, Hyatt C, Johnson S, et al. Lysis of autologous melanoma cells by tumor- 
infiltrating lymphocytes: Association with clinical response. J. Natl. Cancer Inst. 1991 • 
83:932-937. 
2. Chang AE, Shu S. Immunotherapy with sensitized lymphocytes. Cane. Invest. 1992; 
10:357-369. 
3. Shu S, Chou T, and Rosenberg SA. Generation from tumor-bearing mice of 
lymphocytes with in vivo therapeutic efficacy. J. Immunol. 1987; 139:295-304. 
4. Chou T, Chang AE, and Shu S. Generation of therapeutic T lymphocytes from tumor- 
bearing mice by in vitro sensitization. J. Immunol. 1988; 140:2453-2461. 
5. Chou T, Bertera S, Chang AE, and Shu S. Adoptive immunotherapy of microscopic 
and advanced visceral metastases with in vitro sensitized lymphoid cells from mice 
bearing progressive tumors. J. Immunol. 1988; 141:1775-1781. 
6. Shu S, Chou T, and Sakai K. Lymphocytes generated by in vivo priming and in vitro 
sensitization demonstrate therapeutic efficacy against a murine tumor that lacks 
apparent immunogenicity. J. Immunol. 1989; 143:740-748. 
7. Sakai K, Chang AE, and Shu S. Effector phenotype and immunologic specificity of T 
cell-mediated adoptive therapy for a murine tumor that lacks intrinsic immunogenicity. 
Cell. Immunol. 1990; 129:241-255. 
8. Yoshizawa H, Chang AE, and Shu S. Specific adoptive immunotherapy mediated by 
tumor-draining lymph node cells sequentially activated with anti-CD3 and IL-2. JL 
Immunol. 1991; 147:729-737. 
9. Yoshizawa H, Sakai K, Chang AE, and Shu S. Activation by anti-CD3 of tumor- 
draining lymph node cells for specific adoptive immunotherapy. Cell. Immunol. 1991 ; 
134:473-479. 
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