Table 2. Autologous vaccine GM-CSF secretion by dose level.

Transduction for patient 2 fell below the specifications of the trial (17 ng/10⁶ cells), and patient 27 was treated on dose level 2 on a compassionate basis, because of failure to achieve dose level 3 yields. Patient 28 did not have enough vaccine for one fully evaluable treatment at dose level 2 and was treated with 2 × 10⁷ cells. These patients were treated as if specifications were met and were evaluated for all safety and toxicity endpoints but did not occupy a full evaluable patient treatment position for the dose escalation rules. Patient 25 did not have confirmed metastatic disease following surgery and was not treated.

	Without GM-CSF gene transfer GM-CSF, ng/10⁶ cells/24 h	With GM-CSF gene transfer
Patient	Without GM-CSF gene transfer GM-CSF, ng/10⁶ cells/24 h	GM-CSF, ng/10⁶ cells/24 h	MFG-GM-CSF copies/genome
Dose level 1
1^a	1
3^a	1
5^a	Not tested
2^a		17	0.6
6^a		95	1.0
8^a		99	0.7
11^a		51	0.8
Dose level 2
12^a	1
13	19
18^a	1
19^a	9
16^a		42	0.2
23^a		85	0.2
24^a		149	0.5
25		66	0.4
27^a	6
28		69	0.1
Dose level 3
22^a	7
26^a	6

Patients fully evaluable for toxicity and immunological effects.