Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT02639767|
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : December 24, 2015
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: Pemetrexed/Cisplatin Radiation: Pleural Intensity Modulated Radiation Therapy Device: MRI||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2016|
Experimental: pemetrexed/cisplatin with pleural IMRT
This is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.
Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m^2 for pemetrexed in combination with 75 mg/m^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.
Radiation: Pleural Intensity Modulated Radiation Therapy
Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.
A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.
- Dose limiting toxicities (DLT) [ Time Frame: up to 12 weeks ]The NCI Common Terminology Criteria for Adverse Events version 4.0 will be used to grade toxicities during the trial. DLTs are defined as any of the following events occurring during and for the first 12 weeks after completing pleural IMRT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639767
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|Memorial Sloan Kettering West Harrison|
|West Harrison, New York, United States, 10604|
|Principal Investigator:||Marjorie Zauderer||Memorial Sloan Kettering Cancer Center|