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Table 3 Individual Patient Clinical and Biomarker Data

From: Autologous tumor-derived heat-shock protein peptide complex-96 (HSPPC-96) in patients with metastatic melanoma

      

Delayed Type Hypersensitivity (DTH)

γ-interferon ELISPOT*

    
     

Dose Level

DNCB

HSPPC96

Autol. tumor

PBMC

    

OR

TTP

OS

 

M/F

Age

# prior

KPS

Stage**

μg

Grade***

BL

Wk 3

Wk 4

Wk 8

 

Months

Alive

TREATED WITH INDICATOR LESIONS PRESENT

F

53

4

80

4B

2.5

4

0

n/d

n/d

-0.3

0.5

-0.3

0.5

PD

1.6

21.3

 

M

36

2

80

4B

2.5

0

0

n/d

n/d

1.5

11.5

9.5

0.0

SD

1.6

35.0

 

M

56

1

80

4B

2.5

4

n/d

n/d

n/d

n/d

n/d

n/d

n/d

PD

1.9

2.4

 

M

56

3

90

4B

2.5

0

0

0

0

0.0

-1.7

-9.0

-2.3

PD

2.1

38.2

 

M

61

1

90

4B

2.5

3

0

n/d

n

2.5

6.0

5.3

13.3

PD

1.8

18.0

 

M

52

1

80

4B

2.5

0

0

0

0

n/d

n/d

n/d

n/d

PD

1.6

15.9

 

F

56

1

90

3N2C

25

0

0

0

0

0.3

-0.3

-1.3

0.3

PD

1.5

6.0

 

M

16

1

80

3N2C

25

0

0

0

0

2.0

21.5

14.7

1.8

PD

0.2

6.9

 

M

65

5

80

4B

25

3

0

n/d

n/d

n/d

n/d

n/d

n/d

PD

1.2

11.7

 

M

50

1

90

4B

25

4

0

0

0

n/d

n/d

n/d

n/d

PD

1.0

3.7

 

M

47

3

80

4B

25

0

0

0

0

n/d

n/d

n/d

n/d

PD

0.7

24.6

 

M

58

3

80

4B

25

4

0

0

0

0.0

0.0

0.0

0.0

PD

1.7

16.0

 

M

47

2

90

4B

25

0

0

n/d

n/d

0.5

-0.3

0.2

-1.7

SD

60.6

62.7

 

M

32

1

80

4A

100

0

0

0

0

n/d

n/d

n/d

n/d

PD

0.7

6.7

 

M

59

0

80

4B

100

3

0

0

0

-1.3

0.0

0.0

0.0

PD

4.4

24.0

 

M

76

0

80

4B

100

0

0

0

0

0.5

n/d

1.0

n/d

SD

14.6

15.5

 

TREATED IN THE ADJUVANT SETTING

F

63

1

80

3N2C

2.5

3

0

0

0

0.7

2.0

1.3

1.7

PD

4.0

12.3

 

M

47

1

90

3N1

2.5

3

0

n/d

n/d

0.0

1.0

1.0

0.0

NED

99.5

99.5

Alive

F

40

1

90

3N1

2.5

4

0

n/d

n/d

0.0

0.5

0.5

0.5

NED

101.1

101.1

Alive

M

64

1

80

3N2C

2.5

3

0

n/d

n/d

1.0

0.3

1.0

1.3

NED

110.5

110.5

Alive

M

52

1

90

4A

2.5

0

0

n/d

n

-10.7

12.7

7.3

0.0

NED

116.1

116.1

Alive

M

63

0

90

3N2C

25

3

0

0

0

1.0

-0.3

2.0

2.0

PD

1.6

20.4

 

M

59

1

90

3N2A

25

3

0

0

0

0.0

0.0

0.0

 

PD

8.1

18.2

 

M

63

1

90

3N2A

25

3

0

n/d

n/d

0.0

0.0

0.0

0.0

PD

26.7

30.9

 

F

70

3

90

4A

25

0

0

0

0

9.0

0.0

0.5

2.5

NED

110.3

110.3

Alive

M

46

1

80

4B

25

3

n/d

n/d

n/d

n/d

n/d

n/d

n/d

PD

1.7

14.4

 

F

55

1

90

4B

25

4

0

trace

0

n/d

n/d

n/d

n/d

PD

21.3

122.0

Alive

F

41

1

80

4B

25

4

0

0

0

0.0

0.3

0.0

0.0

PD

30.4

119.5

Alive

F

48

0

90

4B

25

3

0

0

0

-0.5

0.5

2.0

1.5

NED

68.8

68.8

Alive

M

44

4

80

4B

25

4

0

0

0

-2.3

13.3

 

-2.9

NED

116.1

116.1

Alive

M

58

0

90

3N2A

100

3

0

0

0

n/d

n/d

n/d

n/d

PD

27.6

41.9

 

F

43

0

90

3N2A

100

4

0

0

0

0.0

0.5

-1.0

-0.3

NED

30.1

30.1

Alive

M

65

2

90

4A

100

3

0

0

0

0.7

0.7

-5.3

-0.3

PD

27.8

119.7

Alive

M

56

1

80

4B

100

3

0

0

0

0.7

0.3

1.3

-0.3

PD

5.4

11.3

 

F

44

1

80

4B

100

0

0

0

0

n/d

n/d

n/d

n/d

PD

15.7

106.8

Alive

M

42

2

90

4B

100

2

0

0

0

14.3

8.3

8.7

14.3

NED

119.6

119.6

Alive

  1. * Mean # spot forming PBMC producing γ-interferon (SFC) in the presence of autologous tumor cells, corrected for mean # SFC in the absence of tumor cells
  2. ** 1992 American Joint Commission on Cancer Staging System
  3. *** For all time points (Baseline, week 4, week 8), DTH was Grade 0 for HSPPC-96, autologous tumor, PBMC in all patients tested
  4. Abbreviations:
  5. # prior Number prior regimens
  6. OR Objective response
  7. Autol. Autologous
  8. OS Overall Survival
  9. BL Baseline
  10. PD Progression of Disease
  11. KPS Karnofsky performance status
  12. SD Stable Disease
  13. M/F Male/Female
  14. TTP Time to prtogression
  15. n/d Not done
  16. Wk Week
  17. NED No evidence of recurrent disease (treated in the adjuvant setting)