Information on Clinical Trials for Mesothelioma

Clinical trials on Mesothelioma aim to evaluate the effect of asbestos upon cells, and how the cells are changed by exposure to this material. Learning the mechanism of asbestos reactions in the body helps to answer many important questions. Clinical Trials also help to optimize treatment and provide newer ways for early diagnosis.

Some Recent and Current Clinical Trials from Around the World Include:

Phase II Feasibility Study of EPP (Extrapleural Pneumonectomy) with Intraperitoneal Heated Cisplatin / Intraoperative Intrathoracic with Sodium Thiosulfate: This study involves a treatment consisting of EPP (removal of both the lung and its lining) followed by chemotherapy (Cisplatin) administered in the operating room. The drug is introduced into the chest and abdomen for one hour after the surgical removal of the cancer. The goal in this study is to use EPP to surgically remove the Mesothelioma and to use the chemotherapy to contain the local spread of the disease.

Randomized Phase II Feasibility Study of Decortication / Pleurectomy without and with Intraperitoneal Heated Cisplatin / Intraoperative Intrathoracic with Sodium Thiosulfate Followed by Adjuvant Cisplatin / ALIMTA® This study is for patients who are surgical candidates for a decortication / pleurectomy (removal of the lining of the lung and visible disease) but are unable to undergo a pneumonectomy (removal of the lung). 

Patients will be randomized into one of two treatment groups. Group 1 will undergo pleurectomy/decortication followed by chemotherapy (cisplatin) administered in the operating room (Cisplatin will be introduced into the chest and abdomen for one hour after the surgical removal of the cancer). Six to eight weeks following surgery, chemotherapy (ALIMTA® plus Cisplatin) will be administered. Group 2 will undergo pleurectomy/decortication. Six to eight weeks following surgery, chemotherapy (ALIMTA® plus Cisplatin) will be given.

Phase III Study of Onconase and doxorubicin Versus doxorubicin Alone, For Patients With Malignant serosa or serous membrane mesothelioma WHO Have Had No over One previous therapy program.

Alimta & Gemcitabine the purpose of this clinical trial is to determine any side effects of these drugs and to test the safety of the treatment. It will also ascertain whether the treatment can prolong the lives of mesothelioma patients, assess whether the combinations of these drugs alters the size of the tumor and whether patients feel any improvement whilst receiving the treatment.

Neoadjuvant Pemetrexed Disodium and Cisplatin followed by Surgery and Radiation Therapy: The purpose of this clinical trial is to study the effectiveness of this treatment followed by surgery and then radiation therapy. The trial also hopes to determine whether the therapy will shrink the tumor and also monitor for any side effects. 

The process will entail an infusion of pemetrexed disodium and an hourly infusion of Cisplatin every three weeks for up to four courses. This is to be followed by Surgery within 3-8 weeks of completion of chemotherapy, radiation therapy beginning 4-8 weeks after surgery and three monthly evaluations for two years.

Intra pleural BG00001: The purpose of this clinical trial is to monitor the effect of treatment on the body’s ability to fight cancer, to study effectiveness of treatment on patients with malignant pleural mesothelioma or malignant pleural effusions, and to monitor for any side effects. The process will entail the placement of a catheter between the lung and chest wall through which treatment will be administered. 

Weekly evaluation for one month; followed by fortnightly evaluation for one month and monthly evaluation for four months ensues. After this, patients will receive six monthly evaluations for fifteen years.

Erlotinib on Patients with Solid Tumours or Liver/Kidney Dysfunction: The purpose of this trial is to assess whether or not the treatment hinders the growth of cancer cells, to assess the effectiveness of the treatment on patients with metastatic or unresectable solid tumors and to assess any side effects from the treatment. The process will entail a once-daily administering of treatment by mouth for as long as benefits continue.

PTK787/ZK 222584: For patients with Unresectable Malignant Mesothelioma. The purpose of this trial is to assess the positive effects of this drug on the growth of tumor cells, to study the effectiveness of the drug on patients and to assess and monitor any side effects. The process will entail administering the drug once daily by mouth for as long as benefits are evident. Evaluations are bi-monthly for a year; four monthly for a year; and twice yearly for a year.

SS1 (dsFv) – PE38 Immunotoxin (for advanced cancer patients): The purpose of this trial is to assess the maximum dose of treatment that can be safely administered to patients with advanced malignancies, monitor and evaluate their response to the treatment and to determine the effects of the drug upon the test group.

Clinical trials are a hope for Mesothelioma patients that a better cure is not far away. The objective behind the trials is to develop new diagnostic tools, new therapeutic agents and effective modalities of treatment.

Treatment Options For Mesothelioma

The Treatment of mesothelioma is a great challenge for surgeons. There are basically three modes of treating any mesothelioma:

1. Surgical removal of the tumor
2. Chemotherapy agents to fight the cancer
3. Use of high-dose x-rays or other high-energy rays to kill cancer cells. (Also called radiation therapy.)

These treatment modalities can either be used alone or in combination. The choice of treatment is patient specific depending upon various factors such as the stage of mesothelioma, its origin and location, metastasis if any and its extent, the pathological findings and also the patient’s age and his expectations.

Surgery

Removal of the cancerous growth is the commonest option, however the type of surgery depends upon the expected results of the surgery.

Chest Tube Drainage and Pleurodesis

Chest tube drainage and pleurodesis is usually effective for a symptomatic relief from pleural effusion. Pleural effusion at times is persistent and recurrent after initial drainage of the fluid. To combat this problem, the pleural space is usually closed using talc slurry or any other sclerosing agent that produces an adhesion.

Pleuroperitoneal Shunt

Shunts can be placed to remove the fluid collection in the pleura. For this purpose a catheter that runs from the pleural to the peritoneal cavity is placed under the skin. This is more often a palliative procedure.

Pleurectomy

Pleurectomy, when used as a palliative procedure, is helpful for people whose tumor growth restricts proper lung expansion. It can be an effective way to control fluid collection.

Potentially Curative Surgeries for Pleural Mesothelioma

Pleurectomy/Decortication - The goal of this surgery is to remove all gross tumor in stage I and selected Stage II. Some cases may require a simultaneous removal of lung (known as pneumonectomy). This usually happens when the tumor cannot be removed without the removal of lung tissue.

For Peritoneal Mesothelioma:

Cytoreductive Surgery is used in combination with a form of chemotherapy called IPHC. The objective of the surgery is to remove all or nearly all of the gross or visible tumor in the peritoneal cavity. The abdominal cavity is then treated with IPHC or Intra-Peritoneal Hyperthermic (heated) Chemotherapy (IPHC).

Chemotherapy

The use of chemotherapeutic agents to kill cancer is not new, however it cannot be considered as a curative treatment for mesothelioma. In mesothelioma, chemotherapy can be used to stop the spread or to slow down the tumour growth, to reduce the tumor size prior to surgery, or to wipe out remnants of disease process after surgery. In palliative care, it may be used to relieve symptoms. Chemotherapy is a treatment of choice for people who are unfit for surgical procedures.

Alimt (Pemetrexed)

Alimta (pemetrexed) is a new multi-targeted antifolate drug, which has been lately approved by the Food and Drug Administration (FDA) for use with Cisplatin. Alimta in combination with Cisplatin is used either for malignant pleural mesothelioma which is unresectable or if the patient is unfit for surgery. The This drug works by jamming the enzymes necessary for DNA copying and cell division. The drug is safe enough to be administered on an outpatient basis every 21 days. 

Alimta is administered as a 10-minute IV infusion followed by a 2-hour infusion of Cisplatin. Researchers claim that patients treated with a combination of Alimta and Cisplatin have longer remission periods and have had less pain and shortness of breath than patients treated with cisplatin alone. This phase III trial however revealed that a decrease in white blood cells might occur as a side effect of the chemotherapy.

Radiotherapy

Radiation therapy may be used alone or in combination with other treatment modalities. In radiation therapy, radiation is used to kill cancer cells and shrink tumors. External radiation uses a source of radiation that is outside the body. On the other hand, internal radiation involves inserting materials that produce radiation through thin plastic tubes into the area where the cancer cells are found. 

Intensity Modulated Radiation Therapy (IMRT) is an aggressive combined modality approach, in which x-rays of varying intensities in conjunction with computer generated images are used to deliver targeted radiation directly to cancer cells, while reducing the amount of radiation to the surrounding healthy tissue. Radiation can also be used as palliative therapy to limit the spread of the tumor. This is mostly used in cases where an infective line is left open by invasive procedures.

It is important to note here that with recent advances in research and clinical trial, newer options of treatment are emerging practically every day. Several of these have further been discussed in the following chapter, which deals with clinical trials.