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
					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.