Table 1. Recent clinical trials evaluating the immunostimulatory potential of cytokines for cancer therapy*.
| Cytokine | Indication(s) | Status | Phase | Route | Co-therapy | Ref. | |
|---|---|---|---|---|---|---|---|
| GM-CSF |
Breast cancer |
Recruiting |
n.a. |
s.c. |
Combined with a multipeptide vaccine |
NCT01660529 |
|
| Chemoradiotherapy-associated mucositis |
Recruiting |
II |
Mouthwash solution |
Combined with vitamin B12 |
NCT01806272 |
||
| Melanoma |
Recruiting |
II/III |
n.a. |
Combined with CSF470 and BCG |
NCT01729663 |
||
| MM |
Recruiting |
n.a. |
s.c. |
Combined with WT1 analog peptide |
NCT01827137 |
||
| NB |
Not yet recruiting |
II |
i.v. |
Combined with ch14.18, irinotecan and temozolomide |
NCT01767194 |
||
| Recruiting |
I |
n.a. |
Combined with hu3F8 |
NCT01757626 |
|||
| I/II |
i.v. |
Combined with ch14.18, IL-2 and isotretinoin |
NCT01592045 |
||||
| NSCLC |
Not yet recruiting |
III |
s.c. |
Combined with a hTERT-derived peptide |
NCT01579188 |
||
| Recruiting |
I/II |
s.c. |
Combined with a hTERT-derived peptide |
NCT01789099 |
|||
| Ovarian cancer |
Recruiting |
I |
s.c. |
Combined with a FBP-derived peptide |
NCT01580696 |
||
| Prostate cancer |
Recruiting |
I/II |
s.c. |
Combined with a hTERT-derived peptide |
NCT01784913 |
||
| Reproductive tract cancer |
Active not recruiting |
I |
s.c. |
Combined with decitabine, PLD and a NY-ESO-1-derived peptide |
NCT01673217 |
||
| IFNα-2a |
Lymphoma |
Completed |
III |
s.c. |
Combined with rituximab |
NCT01609010 |
|
| RCC |
Recruiting |
II |
n.a. |
Combined with bevacizumab, everolimus and a TKI |
NCT01731158 |
||
| IFNα-2b |
High-grade gliomas |
Recruiting |
III |
n.a. |
Combined with radiotherapy and temozolomide |
NCT01765088 |
|
| Ovarian cancer |
Recruiting |
I/II |
s.c. |
Combined with standard chemotherapy and tocilizumab |
NCT01637532 |
||
| n.a. |
Combined with gemcitabine and a p53-derived SLP |
NCT01639885 |
|||||
| Solid tumors |
Recruiting |
II |
n.a. |
Combined with 5-FU |
NCT01658813 |
||
| IFNβ |
Merkel cell carcinoma |
Recruiting |
I/II |
i.t. |
Combined with autologous T-cell transplantation and IL-2 |
NCT01758458 |
|
| IL-2 |
Gastresophageal cancer |
Recruiting |
I |
n.a. |
Combined with IMAB362 and zoledronic acid |
NCT01671774 |
|
| Lung metastases |
Recruiting |
I/II |
Intranasal nebulization |
As single agent |
NCT01590069 |
||
| NB |
Recruiting |
I |
s.c. |
Combined with hu3F8 |
NCT01662804 |
||
| I/II |
i.v. |
Combined with ch14.18, GM-CSF and isotretinoin |
NCT01592045 |
||||
| s.c. |
Combined with ch14.18/CHO and isotretinoin |
NCT01701479 |
|||||
| IL-15 |
HNC Melanoma NSCLC RCC |
Not yet recruiting |
I |
s.c. |
As single agent |
NCT01727076 |
|
| Solid and hematological tumors |
Recruiting |
I |
i.v. |
As single agent |
NCT01572493 |
||
| IL-18 |
NHL |
Recruiting |
I |
n.a. |
Combined with ofatumumab |
NCT01768338 |
|
| IL-21 | Solid tumors | Recruiting | I | i.v. | Combined with anti-PD1 mAbs | NCT01629758 | |
5-FU, 5-fluorouracil; BCG, bacillus Calmette-Guérin; FBP, folate-binding protein; GM-CSF, granulocyte macrophage colony-stimulating factor; HNC, head and neck cancer; hTERT, human telomerase reverse transcriptase; IFN, interferon; IL, interleukin; i.t., intra tumorem; i.v., intra venam; mAb, monoclonal antibody; MM, multiple myeloma; n.a. not available; NB, neuroblastoma; NHL, Non-Hodgkin's lymphoma; NSCLC, non-small cell lung carcinoma; PD1, programmed death 1; PLD, pegylated liposomal doxorubicin; RCC, renal cell carcinoma; s.c., sub cutem; SLP, synthetic long peptide; TKI, tyrosine kinase inhibitor; WT1, Wilms tumor 1. *Limited to trials dealing with investigational cytokines or FDA-approved cytokines employed as “off-label” medications, started after April 1, 2012.