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

From: Current status of granulocyte–macrophage colony-stimulating factor in the immunotherapy of melanoma

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
      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   
  1. ID = intradermal; SC = subcutaneous; IFA = incomplete Freund’s adjuvant; BCG = Bacille Calmette-Guerin.