Active symptom control with or without chemotherapy for mesothelioma (MS-01)

The MS01 trial is a randomized Phase III study comparing active symptom control, the current standard of treatment or active symptom control plus 1 or 3 anti-cancer drugs in patients with malignant mesothelioma. The goal of the trial is to determine which treatment is better at controlling the symptoms of mesothelioma.

Eligibility requirements for this trial are as follows:

Confirmed diagnosis of malignant mesothelioma

Pleural effusion controlled by drainage, pleurodesis or pleurectomy

Prior surgery for mesothelioma, but with residual disease or disease progression

Chest x-ray or CT scan within the last 30 days

Physically able to have chemotherapy

Satisfactory blood test results

Age over 18

You are not eligible for this trial if:

You have had prior chemotherapy for mesothelioma

You have been previously diagnosed with any other type of cancer

You have any other existing serious illness

You are pregnant or breast feeding

Because this is a randomized trial, patients are placed into treatment groups by computer. Neither you nor your doctor will be able to choose which group you may participate in.

Group 1 will receive active symptom control (painkillers, steroids, etc.). The treatment you receive will depend on your individual symptoms.

Group 2 will receive active symptom control plus MVP chemotherapy. This chemotherapy combines the drugs mitomycin C, vinblastine and cisplatin. You will be given chemotherapy every three weeks over a twelve week period.

Group 3 will receive active symptom control plus one chemotherapy drug, vinorelbine (Navelbine). You will be given one injection once a week for six weeks, then no treatment for two weeks, then one injection once a week for an additional six weeks.

If you are interested in participating in this trial, you should ask your doctor for more information on whether it may be suitable in your particular case.

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