Purpose: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with malignant pleural mesothelioma (MPM), choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.
Clinical Trials
Validation of the MiCK Assay
Purpose: Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.
A Phase II Study of Single-agent DOVitinib in Advanced Malignant Pleural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy (DOVE-M)
Purpose: This is a single-arm, open label, two stage, phase II study of dovitinib in patients with advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM using progression free survival (PFS).
Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma
Purpose: The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different dose levels. The investigators want to find out what effects, good and/or bad, it has on the patient and the malignant pleural effusion. A malignant pleural effusion is a build up of fluid in the chest cavity cause by the cancer.
- Arms: Experimental: GL-ONC1
- This is an open-label, dose-escalating, non-randomized, single-center phase I study to determine the dose recommended for further evaluation of the genetically modified vaccinia virus GL-ONC1 when administered intrapleurally as a single dose to patients with malignant pleural effusion.
- Assigned Interventions:
- Biological: GL-ONC1. Patients will be enrolled in groups of three and individually assessed for safety and dose limiting toxicity (DLT).
Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma
Purpose: MPM patients not eligible for surgical procedures like decortication or pleuro-pneumectomy have a median survival of 12 months with palliative chemotherapy. Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is a phase I trial for patients with malignant pleural mesothelioma with pleural effusion testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days before transfer from peripheral blood. CD8 positive T cells will be isolated and re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP which serves as target structure in MPM.
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.
Purpose: HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.
Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.
This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
CRS-207 Cancer Vaccine in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
Purpose: This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such asmesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.
- Experimental Arm: Vaccine plus chemotherapy
- Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)
- Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): Pemetrexed (500 mg/m2) and cisplatin (75 mg/m2)
- Weeks 23 and 26: CRS-207
- Maintenance Vaccinations: CRS-207 every 16 weeks (starting at Week 30) until disease progression
- Assigned Interventions: Biological: Vaccine plus chemotherapy
- CRS-207
- Listeria
- Pemetrexed
- Cisplatin
- ALIMTA
- Platinol
The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma
Rational: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.
Purpose: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.
- Experimental Arm: single arm with Tremelimumab
- Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
- Assigned Intervention:
- Drug: Tremelimumab
Tremelimumab is administered as endovenous infusion - Other Name: CP-675,206
- Drug: Tremelimumab
A Study of LY3023414 in Participants With Advanced Cancer
Purpose: The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer, including but not limited to lymphoma, breast cancer, and mesothelioma. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.
In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast cancer and mesothelioma.
- Experimental Arm: Part A: LY3023414 Once Daily
- LY3023414 administered orally once daily (QD) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation.
- Assigned Interventions:
- Drug: LY3023414
Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
- Drug: LY3023414
- Experimental Arm: Part A2: LY3023414 Twice Daily
- LY3023414 administered orally twice daily (BID) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation.
- Assigned Interventions:
- Drug: LY3023414
Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
- Drug: LY3023414
- Experimental Arm: Part B1 : LY3023414 + Midazolam
- LY3023414 administered orally QD or BID for two 21 day cycles to participants with advanced/metastatic cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 0.2 mg midazolam administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
- Assigned Interventions:
- Drug: LY3023414
Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A. - Drug: Midazolam
0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
- Drug: LY3023414
- Experimental Arm: Part B2: LY3023414 + Letrozole
- LY3023414 administered orally QD or BID for two 21 day cycles to participants with advanced/metastatic breast cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 25 mg Letrozole administered orally QD.
- Assigned Interventions:
- Drug: LY3023414
Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A. - Drug: Letrozole
25 mg administered orally QD.
- Drug: LY3023414
- Experimental Arm: Part B3: LY3023414
- LY3023414 administered orally QD or BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A.
- Assigned Interventions: Drug: LY3023414
Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication for Malignant Pleural Mesothelioma
Purpose: The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication in a phase I and IIa study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model.
