studies as close as possible to 4, 6 , and 8 weeks +/- 2 days. 
8. Baseline CT scan must be done within 4 weeks of treatment. 
9. At any time prior to treatment. 
10. Survival follow-up will be life-long. 
5.0 Stratification Factors 
None. 
6.0 Registration/Randomization Procedure 
6.1 Prior to discussing protocol entry with the patient, call the Research nurse 
to insure that a place on the protocol is open to the patient. 
6.2 To register a patient, call Scott McKay (702-2084) in the Data management 
office. 
6.3 A signed consent form must be on file in the data management office 
before a patient may be registered. 
6.4 Patient eligibility and the existence of a signed consent form will be 
checked by data management personnel before a patient will be 
registered into this study. Dose level will be given. 
6.5 Treatment on this protocol must be given at the University of Chicago on 
an inpatient basis under the supervision of an attending physician in 
Hematology /Oncology. Actual intralesional injection of tumor will be 
carried out by Dr. Gary Sudakoff or one of his associates in the 
Department of Diagnostic Radiology. 
6.6 Treatment must begin within 15 days of registration. 
6.7 Pre treatment tests must be completed within the guidelines specified on 
the test schedule. 
7.0 Drug Information/Protocol Treatment 
7.1 The study drug (VCL-1005) will be supplied by Vical as two sterile vials 
containing (i) HLA-B7 plasmid DNA, and (ii) DMRIE/DOPE lipid mixture. 
Diluent will be lactated Ringer's. All components will be stable for at least 
eight weeks under recommended storage conditions (DNA -20®C, 
DMRIE/DOPE 4°C). The materials will be supplied by Vical Inc. 
[216] 
7.2 Identification and localization of a specific metastasis for injection using ultrasound 
(or CT scan if not visible by ultrasound) meeting the criteria stated in section 3.0 will 
This study drug is composed of plasmid DNA coding for the complete human 
MHC HLA-B7 formulated with the cationic lipid mixture DMRIE/DOPE 
(lipid complex formulation). The DNA concentration is 1.0 mg/ml (see 
Investigator's brochure for complete details of product characteristics and 
preparation). 
Lactated Ringer's is readily available at the site. 
Recombinant DNA Research, Volume 19 
