Table 2.
Recent clinical trials using RNA.
| Cancer type | RNA | Vaccination schedule | Number of study subjects | Immunological response | Clinical response | Reference |
|---|---|---|---|---|---|---|
| Melanoma | Total tumor | 200 μg naked RNA intradermally, biweekly for 8 weeks, followed by monthly injections for 6 months. 150 μg GM-CSF subcutaneously 24 h after RNA injection. | 15 | NA | 2/13 MR 3/13 NED |
[5] |
| Melanoma | Melan-A, tyrosinase, gp100, Mage-A1, Mage-A3, survivin | Arm 1: 3.2–80 μg RNA per antigen + 128 μg protamine intradermally on days 1, 3, 5, weeks 2, 3, 4, 5, 6, 7, 11, 15, 19. 200 μg GM-CSF subcutaneously 24 h after RNA injection. Arm 2: 3.2–80 μg RNA per antigen + 128 μg protamine + 4 mg KLH intradermally on days 1, 3, 5, weeks 2, 3, 4, 5, 6, 7, 11, 15, 19. 200 μg GM-CSF subcutaneously 24 h after RNA injection. |
21 Arm 1: 11 Arm 2: 10 |
Vaccine directed T cells: 2/4 | Arm 1: 1/11 CR 4/11 NED Arm 2: 1/10 NED |
[99] |
| RCC | MUC1, CEA, Her-2/neu, telomerase, surviving, MAGE-1 | Arm 1: 20 μg naked RNA per antigen intradermally on days 0, 14, 28, 42, followed by monthly injections. 100 μg/m2 GM-CSF subcutaneously 24 h after RNA injection. Arm 2: 50 μg naked RNA per antigen intradermally on days 0–3, 7–10, 28, 42, followed by monthly injections. 250 μg/m2 GM-CSF subcutaneously 24 h after RNA injection. |
30, Arm 1: 14 Arm 2: 16 |
CD4+ ELISpot: 3/7 CD8+ ELISpot: 8/9 CD8+ Cr-Release Assay: 7/11 |
Arm 1: 1/14 PR 6/14 SD Arm 2: 9/16 SD |
[81] |
CR: Complete response; MR: Mixed response; NA: Not applicable; NED: No evidence of disease; PR: Partial response; SD: Stable disease.