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

CitationDesign (Enrollment)Ag (Route)GM-CSF form (Route)Coadmin-istration?Study designEffect of GM-CSFSummary 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/vaccineYesSequential:Minimal adjuvant effect Sequential trial cohortsMinimal 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)YesRandomized:Negative on CD4 and CD8 T cells; too few events to differences in survival between groupsDiminished, 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)YesRandomized:Better Ab, worse DTH; more Eos, Dec monocytes; more deathsDiminished 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 daysYes2 × 2:No effect across treatment arms on best overall responseMinimal 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

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