Table 4.
Cancer vaccines testing the adjuvant effect of GM-CSF administered locally at the site of vaccination
| Citation | Design (Enrollment) | Ag (Route) | GM-CSF form (Route) | Coadmin-istration? | Study design | Effect of GM-CSF | Summary effect of GM-CSF |
|---|---|---|---|---|---|---|---|
| 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 |
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Arm A: Peptide Vaccine Alone |
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Arm B: GM-CSF (250 μg/d x 14 out of 28 d) + vaccine |
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Arm C: IFN-α + vaccine |
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| Arm D: GM-CSF + IFN-α + vaccine |
ID = intradermal; SC = subcutaneous; IFA = incomplete Freund’s adjuvant; BCG = Bacille Calmette-Guerin.