Index 
Schema 
1.0 Background 
2.0 Goals 
3.0 Patient Eligibility 
4.0 Test Schedule 
5.0 Stratification Factors 
6.0 Registration/Randomization Procedures 
7.0 Drug Information/Protocol Treatment 
8.0 Treatment Modification Based on Toxicity 
9.0 Ancillary Treatment 
10.0 Toxicity Monitoring and Adverse Reaction Reporting 
11.0 Treatment Evaluation 
12.0 Descriptive Factors 
13.0 Treatment/Follow-Up Decision at Evaluation of Patient 
14.0 Pharmacologic Studies 
15.0 Statistical Consideration and Methodology 
16.0 Pathology Consideration 
17.0 Data Collection Procedures 
Appendix 1 - References 
Appendix 2 - Karnofsky Performance Scale 
Appendix 3 - WHO recommendations for Grading of Acute and Sub-acute Toxic 
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. Escalating doses will be evaluated. Groups of 
patients will receive either escalating doses of an intralesional injection of the test agent into 
one metastatic lesion in a single session (schedule A) or repeated injections at the same dose 
(schedule B). 
Schedule A 
Effects 
Schema 
Number of 
Gm Patients 
me g of DNA 
lip 
A-1 3 
A-2 3 
A-3 3 
10 meg day 1 only 
50 meg day 1 only 
250 meg day 1 only 
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Recombinant DNA Research, Volume 19 
