Table 4 Cancer vaccines testing the adjuvant effect of GM-CSF administered locally at the site of vaccination

Scheibenbogen et al. [75]

Sequential cohorts (n = 43)

Tyrosinase peptides (ID/SC)

Protein (ID/SC) 75 μg/d x 4 d/vaccine

Yes

Sequential:

Minimal adjuvant effect Sequential trial cohorts

Minimal adjuvant effect

1. Peptides alone

2. Peptides + GM-CSF

3. Peptides + KLH

4. Peptides + GM-CSF + KLH

Slingluff et al. [81]

Randomized (n = 121)

Melanoma peptides (ID/SC)

Protein 110 μg (ID/SC)

Yes

Randomized:

Negative on CD4 and CD8 T cells; too few events to differences in survival between groups

Diminished, compared with IFA

1. Peptides + IFA

2. Peptides + IFA + GM-CSF

Faries et al. [71]

Randomized (n = 97)

Whole melanoma cell vaccine (ID)

Protein 200 μg/m²/d x 5 days (ID)

Yes

Randomized:

Better Ab, worse DTH; more Eos, Dec monocytes; more deaths

Diminished compared with BCG

1. Whole cell vaccine + BCG + GM-CSF

2. Whole cell vaccine + BCG

Kirkwood et al. [78]

2 × 2 (n = 120)

MART-1, gp100, and tyrosinase peptides (SC)

250 μg/d x 14 out of 28 days

Yes

2 × 2:

No effect across treatment arms on best overall response

Minimal adjuvant effect

Arm A: Peptide Vaccine Alone

Arm B: GM-CSF (250 μg/d x 14 out of 28 d) + vaccine

Arm C: IFN-α + vaccine

Arm D: GM-CSF + IFN-α + vaccine