A recent study by United Kingdom researchers discovered when considering the mesothelioma surgery options, there is no clear choice. Cancer centers and mesothelioma doctors often disagree about which procedure to offer between extrapleural pneumonectomy (EPP) and pleurectomy/decotication (P/D). The surgeries attempt to either remove and cure the patient or relieve[…]
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New treatment may inhibit the growth of mesothelioma cells
A recent study suggests CARP-1 Functional Mimetics (CFMs) initiated mesothelioma cell death while prohibiting their migration into new colonies. The concept is to mimic the Cell Cycle and Regulatory Protein (CARP) 1 with its ability to assist with apoptosis, or programmed cell death. When new cells become too abundant and[…]
Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)
Purpose: Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen). Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma. This is most commonly caused by exposure to asbestos.
Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is based around controlling the disease and managing the symptoms, rather than curing the disease.
The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two anticancer drugs; Pemetrexed and Cisplatin.
The trial will look into whether there are benefits of adding a third drug called Vorinostat to the treatment.
- Phase II only – Arm I: Active Comparator
- If the patient is randomised into the Vorinostat arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle plus the dose of Vorinostat determined in the phase I study.
- Interventions:
- Drug: Cisplatin.
Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles - Drug: Pemetrexed.
Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles - Drug: Vorinostat.
The dose and frequency of vorinostat will be determined in the Phase I study. Vorinostat will be given concurrently with Cisplatin/Pemetrexed.
- Drug: Cisplatin.
- Phase II only – Arm 2: Placebo Comparator
- If the patient is randomised into the placebo arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle with the placebo for the same number of days as in the vorinostat arm.
- Interventions:
- Drug: Cisplatin.
Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles - Drug: Pemetrexed.
Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles - Drug: Placebo.
Patients randomised into the placebo arm of the trial will receive Cisplatin and Pemetrexed as standard as well as placebo.
- Drug: Cisplatin.
Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
Purpose:
- Background:
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- Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein.
- Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in patients.
- A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them.
- Objectives:
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- To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI clinical trials.
- To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples to learn more about the cellular changes in blood and tissue in tumors of the lung, esophagus and pleura and surrounding structures in the chest.
- Eligibility:
- Patients 18 years of age and older with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung.
- Design:
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- Up to 375 patients may be included in this study.
- Patients undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study.
- All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Patients whose tumor is located on the outside portion of the lung may also undergo thoracoscopy to obtain a tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed through the nose or mouth into the lungs to examine the airways. Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies. For the thoracoscopy a small tube with a light is put through a small hole in the chest to obtain the tumor sample. Both procedures are usually done under general anesthesia. The tissue is examined to identify cell characteristics of people who respond to certain therapies and to identify markers on the surface of the tissue that may be useful in future research and treatment.
- Blood and urine samples are collected from patients.
- Patients who are eligible for a treatment study at NCI are offered participation in the study.
- Patients for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician.
- Patients who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2 to 4 months depending on the nature of their cancer.
