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Mesothelioma Clinical Trials

MESOTHELIOMA CLINICAL TRIALS

CLINICAL TRIAL BASICS

Clinical trials are studies of the safety and/or effectiveness of new drugs being tested on humans. For mesothelioma, trials are being conducted to find a better and more effective means of treatment. Anyone interested in participating in a clinical trial should discuss the particular trial thoroughly with their doctor before a making a decision on whether it is right for them.

All clinical trials carry potential benefits and risks, and it is important that you have a complete understanding of what you might expect. For instance, since clinical trials are often conducted at larger cancer centers, in many cases, travel may be necessary to receive treatment and routine tests. On the other hand, care is provided at top-notch facilities by physicians who are leaders in the field of cancer research. Another benefit would be having access to the new drug before it is widely available, however, the new drug may ultimately be proven not as effective as the “standard” of care.

Eligibility requirements for clinical trials are not the same; each study has specific guidelines to participate. Some trials allow participation after other treatments have failed, while others require that the patient have no prior treatment. Your doctor should be able to advise you which trial might be the best fit in your particular case.

Some treatment trials are “randomized”, meaning the new treatment is compared with a current standard of treatment. Depending on which arm of the protocol you are assigned, you may receive the new treatment or the standard. You should be informed in advance of this eventuality by the doctor conducting the trial. Placebos (pills that contain no active ingredient) are rarely used in cancer trials.

For more information on the terminology associated with clinical trials, visit our clinical trial glossary.

TRIAL PHASES

Though mesothelioma has no cure, there are clinical trials currently underway to test new drugs and procedures in the fight against the disease. All clinical trials or studies are divided into different phases:

Phase I trials usually enroll only a small number of people and test how new drugs or procedures should be administered. Click here for an in-depth description of Phase I trials.

Phase II trials give early information about whether or not a new drug or procedure works and also provide information about safety and benefit. Click here for an in-depth description of Phase II trials.

Phase III trials compare promising new drugs or procedures with the current standard treatment. Large numbers of people from across the nation usually participate in Phase III trials and receive either the new treatment or the standard treatment. Click here for an in-depth description of Phase III trials.

An explanation of the Clinical Trials process

ELIGIBILITY

In order to be sure the study results are accurate, trial participants in all phases must fit a certain profile. Eligibility for mesothelioma trials are often specific as to age, how long it has been since therapy, stage of disease, and other characteristics. To find out about the eligibility requirements and other information for the trials listed below, click on the clinical trial web site listed after each trial or call one of our MW Coordinators toll-free at 1-877-367-6376.

CLINICAL TRIALS AND MEDICARE

If you choose to enter a clinical trial and are on Medicare, it is important that you have a complete understanding of the trial itself, and what costs will or will not be covered under your Medicare policy.

Clinical trials for cancer are currently covered if:

* The trial is funded by the National Cancer Institute (NCI), the NCI-Designated Cancer Centers, the NCI-Sponsored Clinical Trials Cooperative Groups or other Federal agencies that fund cancer research.
* The goal of the trial is to diagnose or treat cancer (cancer prevention trials are not covered).

More on clinical trials and medicare.

CURRENT CLINICAL TRIALS

The National Cancer Institute states that the purpose of most listed clinical trials is to test new cancer treatments or new methods of diagnosing, screening for or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in each clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. (Page on trials of anti-angiogenesis drugs.)

At present, the following trials are actively testing new drugs or treatments for mesothelioma. They are listed by title with a short description and have no particular order or endorsement.

  • Phase II Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma Click here for an abstract of this trial
  • Phase II Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma Click here for an abstract of this trial
  • Phase II Randomized Study of Pemetrexed Disodium Combined With Either Gemcitabine or Carboplatin in Patients With Advanced Malignant Mesothelioma of the Pleura Click here for an abstract of this trial
  • Phase II Study of Induction Combination Chemotherapy Comprising Methotrexate, Vinorelbine Ditartrate, and Cisplatin With or Without Surgery and Adjuvant Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma Click here for an abstract of this trial
  • Phase I Study of Extrapleural Pneumonectomy, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma Click here for an abstract of this trial
  • Phase I Study of SS1 (dsFv)-PE38 Immunotoxin in Combination With Pemetrexed Disodium and Cisplatin in Patients With Unresectable Maligant Epithelial Mesothelioma Click here for an abstract of this trial
  • Phase I Study To Find the Best Dose of SU011248 When Given With Pemetrexed, Pemetrexed and Cisplatin Or Premetrexed and Carboplatin In Patients With Advanced Solid Tumors Click here for an abstract of this trial
  • Phase I Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma Click here for an abstract of this trial
  • Phase I Pilot Study of Wilms Tumor-1 Analog Peptide Vaccine and Sargramostim (GM-CSF) in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Click here for an abstract of this trial

FURTHER INFORMATION – CLINICAL TRIALS

National Institutes of Health (NIH) Clinical Center, Bethesda, MD

The Informed Consent process for patients in clinical trials.

Investigational drugs are those under evaluation in the clinical trial system, but not yet approved by the Food and Drug Administration to be legally marketed and sold. More on investigational drugs.

The process of developing new mesothelioma drugs.

The Department of Veterans Affairs and the National Cancer Institute have an agreement to increase access of eligible veterans to all phases of NCI-sponsored prevention, diagnostic and treatment clinical trial. Click here for more information.

The Community Clinical Oncology Program (CCOP) is a nationwide network that ensures that cancer patients have access to medical care in their own communities.

Sources for information on this page:

National Institutes of Health, Understanding Clinical Trials

National Cancer Institute

Food and Drug Administration