No side effects other than local inflammation have been observed in preliminary studies 
of direct injection of a similar DNA/liposome complex into skin tumors in patients with 
malignant melanoma. There is a theoretical possibility that inflammation of normal 
body tissue producing symptoms such as joint pain, skin rash, or damage to the 
kidneys could occur in response to transfer of the HLA-B7 gene to the tumor. There is 
also the potential risk of damage to the liver if severe inflammation occurs around the 
injected liver tumor. Bleeding and infection are rare complications associated with 
needle biopsies of tumors in the liver or elsewhere within the body. All care will be 
taken to minimize the risk of complication, although the nature and severity of side 
effects is unpredictable. 
Although there is no evidence that the gene transferred to the tumor cells can also enter 
egg cells or sperm cells, this is a theoretical possibility. Therefore, this study may be 
hazardous to an unborn child. There is no information as to whether there are 
significant risks to a fetus carried by a mother who is exposed to the DNA/liposome 
complex. Therefore, only females who are postmenopausal (no longer menstruating), 
and men and women who are surgically sterilized, or agree to use effective means of 
contraception may participate in this study. 
Alternative interventions for this type of malignant disease in the liver spreading from a 
cancer of the colon or rectum would consist of investigative chemotherapy or 
symptomatic care. There is no known cure for this condition. A physician will discuss 
these alternative approaches in detail as they may relate to the patient's decision to 
participate. 
Participants in this investigational program, as in most cancer research, undergo 
periodic monitoring for signs of change in the condition of their tumors, for any toxic 
effects of the research intervention, and to allow the physician-researchers to adjust 
what they are doing. Such monitoring includes physical examinations and studies such 
as x-rays, scans, and blood tests. All such procedures carried out for research purposes, 
as well as room and board and nursing charges at the General Clinical Research Center, 
will not be billed to patient-subjects in this study. Procedures that are solely for 
treatment purposes, as well as pharmacy charges and other ancillary expenses such as 
oral medications prescribed at the time of discharge, will be billed to the patient-subjects 
and/or their insurers. 
The principal investigator. Dr. Joseph Rubin, or a co-investigator, telephone 284-4718, 
may be contacted at any time if the participant has any questions regarding this study, 
if further information about the nature and conduct of the study is required, or if any 
problems result from participation, including a research-related illness. Participation in 
this research study is voluntary and the participant may refuse to enter the study or 
may discontinue participation in the study at any time without jeopardizing present or 
future medical care and treatment or other benefits to which the participant is entitled. 
The investigators may discontinue the participant's study involvement at any time if it 
is felt to be in the participant's best interest, if the participant does not comply with the 
study requirements, or if the study is stopped. Participants will be informed of any 
changes in the nature of the study or in the procedures described if they occur. 
Recombinant DNA Research, Volume 18 
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