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Table 2 Clinical trials of survivin-targeting therapies

From: Survivin, a molecular target for therapeutic interventions in squamous cell carcinoma

Identifier or Reference Sponsors Condition Purpose Intervention 1) Primary
2) secondary outcome measures
Phase/status and outcome First received Last updated/closed
Survivin-targeting immunotherapies and gene therapy
UMIN000000976 University Hospital Medical Information Network Oral cancer Study to evaluate the safety and the efficacy of survivin-2B80-88 peptide vaccination in HLA-A24-positive patients with advanced or recurrent oral cancer. Biological: Survivin-2B80-88 peptide vaccination 1) Safety
2) Efficacy
Phase 1/Completed: survivin-2B peptide vaccination was safe and had therapeutic potential for oral cancer patients Sept 1, 2003 Feb 01, 2011
NCT01250470 Roswell Park Cancer Institute Malignant glioma Study the side effects of survivin peptide vaccine therapy when given together with sargramostim in treating patients with malignant glioma. Other: Laboratory Biomarker Analysis
Drug: Montanide ISA-51/Survivin Peptide Vaccine
Biological: Sargramostim
1) Safety and toxicity
2) Immune response
Phase I/Completed Nov 24, 2010 Feb 24, 2017
NCT02851056 H. Lee Moffitt Cancer Center and Research Institute Multiple Myeloma Test the safety and immune responses of a new survivin vaccine and its effects on multiple myeloma cancer, when administered before and after their autologous hematopoietic cell transplant (HCT). The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC: AdmS) Biological: Survivin Vaccine
Procedure: Autologous Hematopoietic Cell Transplantation
Biological: Prevnar 13
Drug: Granulocyte-colony Stimulating Factor
1) Safety of DC: AdmS when administered to patients with myeloma before and at day +21 after autologous hematopoietic stem cell transplant.
2) The ability of DC: AdmS to induce T cell immune responses against survivin when administered to patients with myeloma
Recruiting July 28, 2016 Dec 7, 2016
NCT00108875   Malignant Melanoma Pancreatic Cancer, Colon, Cancer, Cervical Cancer Evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma. Biological: Survivin peptide vaccine 1) Progression-free survival, Overall survival, Immunological response
2) Best response
Phase 1
Phase 2/Unknown
April 19, 2005 July 27, 2006
NCT00961844 Oslo University Hospital Metastatic Malignant Melanoma Study the safety and effectiveness of chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell expansion after lymphodepletion for the patients who show an immune response. Biological: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion
Drug: Temozolomide
1) Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA.
2) Evaluation of immunological responses, time to disease progression and survival time
Phase 1
Phase 2/Terminated
Aug 12, 2009 Aug 2014
NCT00573495 University of Pennsylvania Breast Cancer Study on how to activate the immune system with a vaccine, which made up of two proteins found in breast cancer: telomerase and survivin. Biological: hTERT/Survivin Multi-Peptide Vaccine 1) Safety
2) Immunologic response
Phase 1/Completed Dec 12, 2007 Sept 27, 2016
NCT00074230 University Hospital Erlangen Melanoma (Skin) Study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients with stage IV cutaneous melanoma. Biological: Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin 1) Safety and tolerability, overall survival.
2) Immune response and disease progression
Phase 1
Phase 2/Completed
Dec 10, 2003 May 11, 2015
NCT02323230 ImmunoVaccine Technologies, Inc. Diffuse Large B-Cell Lymphoma Assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant. Biological: DPX-Survivac
Drug: Cyclophosphamide
1) Objective response rate
2) Immune response and levels of cell mediated immunity targeting the survivin epitopes
Phase 2/Recruiting Dec 12, 2014 Dec 14, 2015
NCT01416038 ImmunoVaccine Technologies, Inc. Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. Biological: DPX-Survivac
Drug: low dose cyclophosphamide (oral)
1) Number of reported adverse events and Progression free survival
2) Levels of cell mediated immunity targeting the survivin epitopes
Phase 1
Phase 2
Aug 9, 2011 Dec 14, 2015
NCT02688673, NCT02693236, NCT01924156 Affiliated Hospital to Academy of Military Medical Sciences Small- Cell Lung Cancer, Esophagus Cancer, Renal Cell Carcinoma Evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells to treat cancer patients Biological: adenovirus-transfected autologous DC vaccine plus CIK cells 1) Objective rate response (CR + PR) as measured by RECIST criteria
2) Number of participants with adverse events
Phase 1
Phase 2/Ongoing
2013-2016 2016
Survivin-targeting small molecule therapies
NCT00537121 Roswell Park Cancer Institute Esophageal Cancer, Gastric Cancer, Liver Cancer Study the side effects and best dose of vorinostat (SAHA) when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced upper gastrointestinal cancer. SAHA suppresses tumor cells growth by blocking HDAC that also involve inhibition survivin and TGF-beta signaling. Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: vorinostat
Other: pharmacological study
1) Maximum tolerated dose (MTD) of vorinostat (SAHA) when administered continuously and intermittently with standard doses of irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI). Recommended phase II dose (RPTD) of SAHA when administered continuously and intermittently with standard doses of FOLFIRI
2) Toxicity of the SAHA and FOLFIRI combination. Effects of SAHA and FOLFIRI combination on TGF-β signaling and survivin expression. Response rate. Progression-free survival Overall survival
Phase 1/Completed Sept 27, 2007 June 26, 2013
NCT01398462 JW Pharmaceutical Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome Myelofibrosis Test safety, efficacy, and antitumor activity of CWP232291. This drug targets beta-catenin for degradation and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1 and survivin Drug: CWP232291 1) To determine Maximum Tolerated Dose (MTD)and dose limiting toxicities (DLTs)
2) Pharmacokinetics, and assess the anti-tumor activity
Phase 1 July 17, 2011 March 7, 2016
NCT00664586 Erimos Pharmaceuticals Refractory Solid Tumors
Lymphoma
Continuous infusion study designed to explore if constant concentration over time adds to the effectiveness of terameprocol without increasing toxicity. It will also explore weekly dosing as an option. Drug: Terameprocol (EM-1421) 1) To determine Maximum Tolerated Dose (MTD)and dose limiting toxicities (DLTs)
2) Assess the anti-tumor activity
Phase 1/Terminated due to funding constraints April 21, 2008 Feb 20, 2016
NCT00664677 Erimos Pharmaceuticals Leukemias:
AML, ALL, ATL, CML-BP, CLL, MDS, CMML
Determine the safety, maximum tolerated dose,dose limiting toxicity of Terameprocol and determine the pharmacokinetics of Terameprocol given as intravenous infusion. Drug: Terameprocol (EM-1421) 1) To determine Maximum Tolerated Dose (MTD)and dose limiting toxicities (DLTs)
2) Pharmacokinetics and assess the anti-tumor activity
Phase 1/Terminated due to funding constraints April 21, 2008 Feb 20, 2016
[223] H. Lee Moffitt Cancer Center Advanced solid malignancies or lymphoma Determine the maximum-tolerated dose (MTD) and assess the safety, pharmacokinetics, and preliminary evidence of antitumor activity Drug: YM155
(First human trial)
1) To determine Maximum Tolerated Dose (MTD) and dose limiting toxicities (DLTs)
2) Pharmacokinetics of drug and preliminary evidence of 2anticancer activity
Phase 1/Completed: Drug is safe to administer with no severe toxicities, and showed antitumor activity   Nov 10, 2008
[224] National Cancer Institute Advanced non–small-cell lung cancer (NSCLC). Evaluate the antitumor activity and safety of YM155, a novel, small-molecule suppressor of survivin, as single-agent therapy. Drug: YM155 1) Safety and tolerance
2) Anti-tumor activity
Phase 2/Completed: Drug showed modest single-agent anti-tumor activity, and a favorable safety/tolerability profile was reported   Sept 20, 2009
[226] Georgetown University Hospital Refractory diffuse large B-cell lymphoma Study toxicity and efficacy YM155 Drug: YM155 1) Safety and tolerance
2) Anti-tumor activity
Phase 2/Completed: Drug was well tolerated and showed limited anti-tumor activity as a single agent   June 15, 2012
NCT00514267 Astellas Pharma Inc Prostate Cancer
Tumors
Determine the feasibility and safety of administering YM155 in combination with docetaxel Drug: YM 155
Drug: Docetaxel
Drug: Prednisone
1) Occurrence of dose limiting toxicities
2) Assessment of safety, efficacy and pharmacokinetics
Phase 1
Phase 2/Completed
Aug 7, 2007 July 23, 2015
NCT01100931 National Cancer Institute NSCLC
Solid Tumors
Determine the efficacy of the combination of carboplatin, paclitaxel, and YM155 in the treatment of non-small-cell lung cancer Drug: YM155
Drug: Carboplatin
Drug: Paclitaxel
1) Assessment of safety, efficacy and pharmacokinetics
2) Anti-tumor activity
Phase 1
Phase 2/Completed
April 8, 2010 Sept 29, 2015
Diagnostic
NCT00315653 Fujirebio Diagnostics, Inc. Bladder Cancer Evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria Procedure: Urine Sampling Evaluation of the Survivin Urine mRNA Assay Completed April 18, 2006 March 12, 2008
NCT02016833 PX Biosolutions Ovarian Serous Adenocarcinoma, Undifferentiated Carcinoma of Ovary, Cervical Cancer, Cervical Intraepithelial Neoplasia, Grade 3
Acute Myeloid Leukemia, Chronic Myeloid Leukemia
Establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients Procedure: Blood Sampling Development and validation of ELISpot and tetramer assays Completed Dec 5, 2013 April 29, 2015