Clinical trial NCT02639767: Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
Official title: A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Malignant Pleural Mesothelioma
Keywords: Pemetrexed
Cisplatin
Intensity Modulated Radiation Therapy
15-304
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. This radiation technique is called pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When given after chemotherapy, pleural IMRT has demonstrated promising results with respect to keeping mesothelioma under control longer. However, the investigators want to determine if giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural IMRT.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
* No plans for surgical resection
* Stage T1-4, N0-3, M0
* No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
* Prior chemotherapy regimens ≤1
* Age ≥18 years
* Karnofsky performance status ≥ 80%
* Pulmonary function tests as follows: DLCO\>50% predicted
* Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values

  * Absolute neutrophil count ≥ 1,500/mcL
  * Platelets ≥ 100,000/mcL
  * Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
  * AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN

Exclusion Criteria:

* Pregnant or lactating women, or men or women not using effective contraception
* Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
* Patients with a concurrent active malignancy (with the exception of skin cancer)
* Patients with serious unstable medical illness
* Patients with idiopathic pulmonary fibrosis
* Patients with NYHA heart failure class \>2
* Patients with only one kidney that is ipsilateral to the mesothelioma
* Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
* Patients meeting the following exclusion criteria will be excluded from the MRI portion only:
* Metallic implant, e.g. pacemaker, defibrillator
* Unmanageable claustrophobia
* High risk for nephrogenic systemic fibrosis

Primary outcomes:
measure: Dose limiting toxicities (DLT)
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center at Phelps
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marjorie Zauderer
role: PRINCIPAL_INVESTIGATOR
References: