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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborators: |
Novartis Pharmaceuticals Dana-Farber Cancer Institute University of Pennsylvania |
| Information provided by (Responsible Party): | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01024946 |
Purpose
For patients with malignant pleural mesothelioma that has grown despite treatment with standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied. The patients' physical state, changes in the size of the tumor, and laboratory findings taken during the study will help us decide if everolimus is safe and effective.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma |
Drug: everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity |
| Estimated Enrollment: | 39 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pts getting everolimus
This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
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Drug: everolimus
Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity of toxicity encountered. One cycle will be considered 28 days. Patients will have CT scans to evaluate for response after cycle 1 and cycle 2, and then every two cycles thereafter.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate hepatic function as defined by:
Patients must have adequate bone marrow function as defined by:
Exclusion Criteria:
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Severely impaired lung function as evidenced by:
o DLCO < 35% of the normal predicted value and/or O2 saturation that is ≤ 88% at rest on room air
Contacts and Locations| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Principal Investigator: | Lee Krug, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01024946 History of Changes |
| Other Study ID Numbers: | 09-142 |
| Study First Received: | December 2, 2009 |
| Last Updated: | September 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
mesothelioma pleural RAD001 Everolimus 09-142 |
thoracic lung epithelioid sarcomatoid |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Everolimus Sirolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |