Table 2.
Clinical Trials of Combination Therapy with Allogeneic GM-CSF-Secreting Vaccines
| Patient population |
Number of patients |
Combination Drug Therapy |
Immunologic outcome |
Clinical observations | Ref |
|---|---|---|---|---|---|
| Metastatic pancreatic cancer |
50 | CY 0 mg/m2 (n = 20)vs. CY 300 mg/m2 (n =30) |
Increased mesothelin- specific immunity with CY 300 mg/m2 |
Median survival rates vaccination alone = 2.3 months vaccination + CY = 4.3 months |
1 |
| Metastatic breast cancer |
28 | CY 0,200,250,350 mg/m2 DOX 0,15,25,35 mg/m2 (factorial design of various dose combinations) |
HER-2-specific DTH, with HER-2- specific antibody levels enhanced by 200 mg/m2 CY and 35 mg/m2 DOX |
Not assessed | 2 |
| Prostate cancer patients |
12 | Ipilumimab 0.3,1,3,5 mg/kg | Antibodies to filamin B, PSMA and NY-ESO-1 |
Late-onset PSA declines >50% in 5 patients with response durations 6.7–23.1 months 4/5 had stable disease on bone scan for at least 12 months 5/6 patients with Grade 2/3 immune breakthrough events (hypophysitis, alveolitis) |
3 |
GM-CSF=granulocyte-macrophage colony-stimulating factor; CY=cyclophosphamide; DOX=doxorubicin; HER-2=human epidermal growth factor receptor-2; DTH=delayed type hypersensitivity; PSMA=prostate-specific membrane antigen; PSA=prostate-specific antigen; References;