6 . 0 PRE-TREATMENT EVALUATION 
6.1 A complete history and physical examination including 
documentation of all measurable disease , especially involvement 
of the peritoneum and other site of initial bulk disease which 
were established initially. A dental examination is also 
recommended. 
■I 
6.2 Laboratory studies include CBC, platelet count, differential, SMA 
12, liver and renal function tests, coagulation studies (PT, PTT, 
Fibrinogen, FSP) , and cytogenetics. PCR for MDR-1 will be 
conducted as outlined above. 
6.3 Bone marrow aspirate and biopsy for morphology, pathology, and 
cytogenetics . 
6.4 An EKG and CXR will be performed on all patients. A urinalysis 
will also be obtained before therapy. 
\ 1 
6.5 Pulmonary function studies with diffusion capacity. 
7.0 EVALUATION DURING STUDY (SEE APPENDIX F) 
7.1 CBC, platelet, differential every 1-2 days during the initial 
induction. 
7 . 2 SMA 12 , lytes every three to seven days and as indicated 
additionally. 
7.3 Bone marrow aspirate and biopsy for morphologic pathology, 
cytogenetics, and PCR for MDR-1 should be performed at marrow 
recovery (when AML count > 2 000 /cm mm) . 
7.4 Upon marrow recovery, a full work-up including CBC, platelet 
count and differential, SMA 12, and marrow studies including 
cytogenetics will be performed. Studies at remission will 
include CBC, platelet count, differential and SMA 12 every 1-4 
weeks, marrow studies with cytogenetics every 6 months and as 
indicated by disease status. 
7.5 The following will be collected before and after vector exposure 
and after hematopoietic recovery and on a six monthly basis for 
five years after transplant: 2 x 10 6 cells for MDR-1 PCR, 2 x 10 
blood and marrow cells for viral PCR, 2 x 10 6 cells for NIH3T3 
viral amplification studies, 1 x 10 7 cells for Southerns and 10 
cc of a red top tube for Western blots for viral antibodies. 
8.0 CRITERIA FOR RESPONSE AND TOXICITY (APPENDIX E) 
8.1 Criteria for toxicity will be as follows: Failure of the marrow 
to engraft and the need to use back-up collections of ^ 
hematopoietic cells from the marrow or peripheral blood for 
reconstitution. 
Recombinant DNA Research, Volume 17 
[672] 
