Table 5.
Clinical trials of tumor cell-derived vaccines.
| Vaccine Type | Strategy | Condition or disease | Treatment(s) | Trial phase | NCT number | Dose and schedules |
|---|---|---|---|---|---|---|
| Whole tumor cell vaccine | Autologous or allogeneic tumor | |||||
| Mesothelioma | Drug: Celebrex | I | NCT01258868 | 1 × 107 to 1 × 108 patient tumor cells every four weeks for six injections; if subject shows immune response, vaccine will be given every three months from months 9–24 | ||
| Esophageal cancer | ||||||
| Lung cancer | ||||||
| Thoracic sarcomas | ||||||
| Thymoma | ||||||
| Metastatic solid tumors | Biological: Tumor cell vaccine | I, II | NCT00148993 | – | ||
| Malignant mesothelioma | Biological: PA-1-STK ovarian carcinoma vaccine | I | NCT00006216 | – | ||
| Drug: Ganciclovir | ||||||
| Melanoma | Biological: autologous, DNP-modified vaccine (M-Vax) | I, II | NCT00257465 | Four doses of 5.0 × 106, 2.5 × 106, 0.5 106, or 0 cells; eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6-month period; all participants receive low dose cyclophosphamide and BCG | ||
| Biological: autologous, DNP-modified melanoma vaccine | ||||||
| Biological: autologous, DNP-modified vaccine | ||||||
| Non-small cell lung cancer | Drug: 1650-G Vaccine | II | NCT00654030 | Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study. | ||
| Lung cancer | Drug: autologous tumor cell vaccine | I | NCT00098917 | Patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the absence of unacceptable toxicity. | ||
| Drug: therapeutic autologous dendritic cells | ||||||
| Colorectal neoplasms | Biological: autologous tumor cell + CpG vaccine | I | NCT00780988 | Patients will receive subcutaneous vaccination at weeks 1 and 2 after resection. If needed patients will receive chemotherapy for tumor reduction. When disease is controlled off chemotherapy, patients will receive a conditioning regimen of fludarabine (30 mg/m2 daily × 3 days) followed by intensive fractionated total body irradiation. The dose of fTBI will be escalated using a 3 + 3 design to ensure safety and will range from 400 to 800 Gy. The patient will then undergo hematopoietic and immune cell rescue. They will undergo a third vaccination within 7–14 days after transplant. | ||
| Multiple myeloma | Biological: autologous tumor cell vaccine | I | NCT00469820 | – | ||
| Plasma cell neoplasm | Biological: peripheral blood lymphocyte therapy | |||||
| Skin melanoma | Biological: bystander-based autologous tumor cell vaccine | II | NCT00101166 | Intradermal vaccine injections at 28-day intervals for a total of three immunizations (performed on days 1, 29, and 57) | ||
| Chronic myeloid leukemia | Biological: Allogeneic tumor cell vaccine | I, II | NCT00162513 | Six vaccine doses, 2 weeks apart. | ||
| Breast cancer | Biological: allogeneic tumor cell vaccine, autologous tumor cell vaccine, recombinant interferon alfa, recombinant interferon gamma, sargramostim | II | NCT00002475 | Treatment repeats every 2 weeks for three courses. | ||
| Colorectal cancer | ||||||
| Kidney cancer | ||||||
| Lung cancer | ||||||
| Malignant mesothelioma | ||||||
| Pancreatic cancer | ||||||
| Genetically modified tumor cell | ||||||
| Ewing's sarcoma | Biological: Vigil™ | I | NCT01061840 | Once a month and up to 12 doses. | ||
| Non-small cell lung cancer | ||||||
| Liver cancer | ||||||
| Ovarian cancer | Biological: Vigil™ | II | NCT01309230 | Intradermal autologous Vigil™ (1.0 × 107 cells/injection, maximum of 12 vaccinations) | ||
| Stage III/IV ovarian cancer | Biological: Vigil™ vaccine | II | NCT01551745 | Intradermal injection of Vigil™ (1.0 × 107 cells once a month, maximum of 12 doses); Bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks | ||
| Drug: Bevacizumab | ||||||
| Advanced melanoma | Biological: Vigil™ vaccine | II | NCT01453361 | Intradermal injection (1 × 107 cells once a month, maximum of 12 doses) | ||
| Breast cancer | Biological: autologous, lethally irradiated breast cancer cells | I | NCT00880464 | Doses of approximately 1 × 107, 4 × 106, 1 × 106, or 1 × 105 cells (depending on the final cell yield) administered on days 1, 8, 15, 29, and then every 2 weeks until the vaccine supply is exhausted or the patient is removed from study | ||
| Breast cancer | Biological: autologous, lethally irradiated breast cancer cells | I | NCT00317603 | Administered on days 1, 8, 15, 29, and then every 2 weeks until the vaccine supply is exhausted | ||
| Lung neoplasm | Biological: Lucanix | II | NCT01058785 | Patients are randomized to receive either 1.25 × 107, 2.5 × 107, or 50 × 107 cells per injection once a month (maximum of 16 injections) | ||
| Bronchogenic carcinoma | ||||||
| Colon cancer | Biological: Vigil™ vaccine<Drug: placebo | II | NCT01505166 | Patients will receive 1 × 107 cells (Group A) or placebo (Group B) via 5–12 doses of intradermal injections starting 4–8 weeks post-surgery (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive oxaliplatin 85 mg/m2, l-leucovorin 200 mg/m2, fluorouracil 400 mg/m2 IV bolus, and fluorouracil 2400 mg/m2 for 46 h continuous infusion every 14 days for six cycles (one cycle = 4 weeks) | ||
| Acute myeloid leukemia | Biological: AML cell vaccine | I | NCT02493829 | – | ||
| Myelodysplastic syndromes | ||||||
| Lung neoplasms | Biological: Hyperacute lung cancer cell vaccine | I | NCT00073398 | Intradermal injection every four weeks for four cycles. Dosage will vary from 3 × 106 to 100 × 106 HyperAcute lung cancer vaccine cells | ||
| Pancreatic cancer | Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine | II | NCT01088789 | Administered every 6 months | ||
| Metastatic breast cancer | Biological: KS24.22 cells | I | NCT01127074 | The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. | ||
| Kidney cancer | Biological: IL-2 | II | NCT00031564 | At 3–6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously once on days 1, 29, and 57; 6 weeks after the first vaccination, patients receive IL-2 subcutaneously for 5 days a week for 6 weeks | ||
| Biological: B7-1 | ||||||
| Metastatic colorectal cancer | Drug: CYBiological: GVAXDrug: SGI-110 | I | NCT01966289 | Cyclophosphamide is administered intravenously at 200 mg/m2; GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells; SGI-110 is administered subcutaneously at 60 mg/m2; each cycle is 28 days | ||
| Prostate cancer | Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine | I, II | NCT00140374 | – | ||
| Prostate cancer | Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine | I, II | NCT00140387 | – | ||
| Colorectal cancerMetastatic cancer | Biological: colon GVAXDrug: cyclophosphamide | I | NCT00656123 | Dose escalation of 1.4 × 108 to 7 × 108 cells, administered in up to 15 intradermal injections on day two of cycles 1–4; cyclophosphamideis administered intravenously at 200 mg/m2 on day 1 of cycles 1–4 | ||
| Prostate cancer | Biological: GM-CSF gene transduced allogeneic vaccine GVAX | I, II | NCT00122005 | – | ||
| Melanoma | Biological: Tag-7 gene modified inactivated tumor cells | I, II | NCT04180774 | Vaccinations every 3 weeks, dosage of 10 million transfected and inactivated tumor cells | ||
| Kidney cancer | ||||||
| Pancreatic cancer | Biological: GVAX pancreatic cancer vaccine | II | NCT00084383 | First vaccination 6–8 weeks after surgery; eligible patients receive three additional vaccinations at one-month intervals; patients who remain disease-free receive a fifth booster at 6 months following the fourth vaccination | ||
| Lung cancer | Biological: GVAX lung cancer vaccine | II | NCT00074295 | Patients receive GVAX lung cancer vaccine intradermally (ID) (6–7 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity. | ||
| Surface modified tumor cells | ||||||
| Colorectal cancer | Biological: Autologous or Allogeneic tumor cells | I, II | NCT00722228 | Five vaccine doses, 3 weeks apart, injected subcutaneously | ||
| Ovarian cancer | ||||||
| Gastric cancer | ||||||
| Breast cancer | ||||||
| Lung cancer | ||||||
| Kidney cancer | ||||||
| Melanoma | ||||||
| Dendritic cells loaded with pulsed tumor cell lysate-based vaccine | Autologous dendritic cells & autologous/allogeneic tumor lysate | |||||
| Metastatic pancreatic cancer | Biological: KLH-pulsed autologous dendritic cell vaccine | II | NCT00868114 | Weekly dose of 5 × 107 KLH-pulsed autologous dendritic cells for 3 weeks | ||
| Non-Hodgkin's lymphoma | Biological: tumor-pulsed dendritic cells | III | NCT00006434 | – | ||
| Stage IV colorectal cancer | Biological: autologous dendritic cells loaded with autologous tumour homogenate | II | NCT02919644 | Intradermal injection of autologous dendritic cells loaded with autologous tumor homogenate (day 1); subcutaneous injection of IL-2 for five days (days 3–7) | ||
| Curative resection | Drug: IL-2 | |||||
| Glioblastoma | Biological: autologous dendritic cells pulsed with tumor lysate antigen vaccine | II | NCT03014804 | Vaccination on days 0, 7, and 14, and at weeks 4, 6, 8, 11, 14, 17, and 20 | ||
| Drug: Nivolumab | ||||||
| Giant cell glioblastoma | Biological: malignant glioma tumor lysate-pulsed autologous dendritic cell vaccineDrug: Temozolomide | I | NCT01957956 | Intradermal vaccinations with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine on day 1 or on days 1, 3, and 5 | ||
| Glioblastoma | ||||||
| Gliosarcoma | ||||||
| Metastatic melanoma | Drug: GM-CSF | II | NCT00948480 | A series of eight vaccinations administered over 6 months | ||
| Renal cell carcinoma | Biological: allogeneic DCs and autologous RCC tumor derived cells | I | NCT00050323 | – | ||
| Ovarian neoplasms | Biological: CSC-DC | I, II | NCT02178670 | – | ||
| Sarcoma | Hematopoietic stem cell transplantation | II | NCT00405327 | – | ||
| Neuroblastoma | ||||||
| Wilm's Tumor | ||||||
| Kidney cancer | Biological: autologous tumor cell vaccine, keyhole limpet hemocyanin, therapeutic autologous dendritic cells | II | NCT00093522 | Arm I: 3 weeks after leukapheresis, patients receive intradermal vaccination comprising DCs loaded with autologous tumor lysate and KLH once every 14 days for a total of four injections; Arm II: 2 weeks after leukapheresis, patients receive fludarabine intravenously for 15–30 min once daily for 3 days; at 5 weeks after leukapheresis, these patients also receive DC vaccine as in arm I | ||
| Drug: fludarabine phosphate | ||||||
| Procedure: conventional surgery | ||||||
| Lung cancer | Biological: autologous tumor cell vaccine, therapeutic autologous dendritic cells | I | NCT00023985 | Patients receive autologous tumor lysate-pulsed dendritic cell vaccine subcutaneously twice, 4 weeks apart | ||
| Procedure: conventional surgery | ||||||
| Mesothelioma | Drug: MesoPher | II, III | NCT03610360 | Starting 9–13 weeks after the last chemotherapy dose, three biweekly injections with MesoPher; if stable, an additional two injections at weeks 18 and 30 (a maximum of five doses) | ||
| Fusion cell-based vaccine | DC-tumor fusion cell | |||||
| Breast cancer | Biological: Dendritic Cell/Tumor Fusion Vaccine | I, II | NCT00622401 | A subcutaneous injection of tumor cells fused with dendritic cells every 3 weeks for a total of 9 weeks | ||
| Drug: Interleukin-12 | ||||||
| Acute myelogenous leukemia | Drug: decitabine | I | NCT03679650 | Two vaccines, 3 weeks apart, with potential for a booster vaccine | ||
| Biological: DC/AML fusion cells | ||||||
| Renal cancer | Biological: Dendritic Cell Tumor Fusion Vaccine | I, II | NCT00458536 | The treatment will consist of 3 vaccinations of fused cells given by an injection under your skin at 3-week intervals. The first six participants will receive only the study vaccine. The remaining participants will receive the study vaccine combined with GM-CSF. | ||
| Drug: GM-CSF | ||||||
| Multiple myeloma | Biological: Dendritic Cell Tumor Fusion Vaccine | I | NCT00459069 | Administered on weeks 0, 3, and 6 | ||
| Ovarian cancer | Drug: imiquimod, GM-CSFBiological: dendritic cell tumor fusion vaccine | II | NCT00799110 | Subcutaneous vaccinations once every 3 weeks for a total of three vaccines | ||
| Primary peritoneal cancer | ||||||
| Fallopian tube cancer | ||||||
| Multiple myeloma | Single agent | I | NCT00458653 | Subcutaneous administration every 4 weeks for three doses | ||
| Metastatic melanoma | Single agent | I | NCT00626860 | Vaccinations administered at 3-week intervals for 2–3 doses | ||
| Glioblastoma | Biological: dendritic cell/tumor fusion vaccineDrug: IL-12, Temozolomide (TMZ) | I, II | NCT04388033 | Surgery is followed by concomitant radiation and TMZ-chemotherapy (75 mg/m2 per day for 42 days); maintenance chemotherapy with TMZ is administered at 150–200 mg/m2/day for 5 days in each 28-day cycle; fusion cells are injected intradermally; 6 μg of IL-12 is injected twice subcutaneously over an interval of 1 h | ||
| Glioma | ||||||
| Neuroectodermal tumors | ||||||
| Leukemia | Drug: autologous tumor cell vaccine | I | NCT00100971 | After completing chemotherapy, patients receive vaccine subcutaneously every 2 weeks for a total of four doses | ||
| Drug: therapeutic autologous dendritic cells | ||||||