Malignant Mesothelioma Clinical Trial
Official title:
Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
OBJECTIVES: Primary - To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin. Secondary - To determine the overall survival of patients treated with this regimen versus observation. - To evaluate the frequency of responses in patients treated with this regimen. - To assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6). - Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Completed |
NCT00821860 -
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
|
Phase 3 | |
| Completed |
NCT00075699 -
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural 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 |
NCT00004920 -
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
|
Phase 3 | |
| Completed |
NCT00004254 -
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
|
Phase 2 | |
| 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 |
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 | |
| Completed |
NCT00513877 -
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 |