Malignant Mesothelioma Clinical Trial
Official title:
Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with brentuximab vedotin. SECONDARY OBJECTIVES: I. To evaluate the response rate, progression-free and overall survival, and safety/toxicity of brentuximab vedotin in CD30+ malignant mesothelioma. II. To prospectively evaluate the incidence of CD30+ expression in malignant mesothelioma during the screening process. III. To determine whether CD30+ expression levels in tumor tissue correlate to response to brentuximab vedotin. EXPLORATORY OBJECTIVES: I. To collect archival or new tissue and blood for correlative studies. II. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens. III. Exploratory analysis: Bank peripheral blood at baseline for subsequent cytokine or reverse phase protein array (RPPA). OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months and then every 6 months thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Completed |
NCT00075699 -
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 3 | |
| Completed |
NCT00821860 -
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
|
Phase 3 | |
| Completed |
NCT00004033 -
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT03678350 -
Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
|
Phase 1 | |
| Recruiting |
NCT02580747 -
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
|
Phase 1 | |
| Completed |
NCT00398138 -
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
|
Phase 1 | |
| Completed |
NCT00019825 -
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
|
Phase 1 | |
| Terminated |
NCT00898547 -
Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107
|
||
| Active, not recruiting |
NCT00030459 -
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00004183 -
Capecitabine in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00004254 -
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
|
Phase 2 | |
| Completed |
NCT00004920 -
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
|
Phase 3 | |
| Completed |
NCT00005636 -
Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
|
Phase 3 | |
| Completed |
NCT00334594 -
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT01291420 -
Dendritic Cell Vaccination for Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03852823 -
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours
|
Phase 1 | |
| Active, not recruiting |
NCT01649024 -
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00513877 -
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT00372840 -
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer
|
N/A |