1.0 OBJECTIVES 
2.0 BACKGROUND AND RATIONALE 
2.1 Current Therapies for Metastatic Renal Cell Carcinoma 
2.2 Rationale for Cell Based Immunotherapy for Metastatic Cancer: 
Preclinical Data with MFG Retroviral Gene Transfer 
2.3 Feasibility of Producing a GM-CSF secreting Renal Cell Carcinoma 
Tumor Vaccine 
3.0 
STUDY 
DESIGN AND 
TREATMENT PLAN 
3.1 
Overview 
3.2 
Three Stage Phase I Trial 
3.3 
Stage 1: 
Surgery and Cell Preparation 
3.4 
Stage 2 : 
RCC cell Injections 
3.5 
Stage 3: 
Long-Term Follow-Up 
3.6 
Rationale 
for Study Design and Predicted Toxicities 
4.0 PATIENT ELIGIBILITY 
5.0 BIOSTATISTICS 
6.0 REGISTRATION OF PATIENTS 
7 . 0 STUDY PARAMETERS 
8.0 TUMOR RESPONSE CRITERIA 
9.0 TOXICITY EVALUATION 
9.1 Definitions and toxicity criteria 
9.2 Autopsy studies 
9.3 Management of toxicities 
10.0 FORMS TO BE KEPT 
11.0 REPORTING OF ADVERSE DATA 
12.0 INFORMED CONSENT 
13.0 FEDERAL SAFETY STANDARDS AND BIOSAFETY REVIEW PROCESS 
Recombinant DNA Research, Volume 17 
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