Clinical Trials for Mesothelioma Lung Cancer - Basic Info, Trial Phases, Eligibility & Current Clinical Trials

Clinical Trials for Mesothelioma Lung Cancer - Basic Info, Trial Phases, Eligibility & Current Clinical Trials
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Clinical trials are a means of testing new drugs & health products in the market on patients that are most likely to benefit from them. Clinical trials measure the effectiveness & safety of new drugs before they are released to the general public. Cancer clinical trials for mesothelioma are ongoing all over the country and any patient who wishes to undergo one should talk to his/her doctor for eligibility & benefits. It is important to understand that clinical trials are for newly released drugs that could have both benefits & risks. The risks are that the drugs could negatively impact your health, while the benefits are you will receive treatment from top notch doctors who are leaders in the field of medical research. For example, some of the mesothelioma lung cancer clinical trials are conducted by some of the top medical doctors in the US. Since lung cancer clinical trials are done in large US Cancer centers, travel may be necessary.

Characteristics of Clinical Trials & Eligibility

i) Clinical trials have primary and secondary objectives. For example, a primary objective would be to study the direct effects of the drug being tested on the patient population while a secondary objective would be to measure response rates, overall well being of the patients, clinical responses, etc.

ii) Clinical trials have eligibility criteria. For instance, for a new drug called Pazopanib Hydrochloride that was being tested on patients with malignant pleural mesothelioma, the patients must have a measurable sense of the disease, or something closely associated with that disease, such as whole brain radiation that has metastasized into the lungs.

iii) The patients must meet certain requirements before they are eligible for certain lung cancer clinical trials, for example:

- The patient must have life expectancy of >15 weeks
- Platelet count (# of red blood cells) >= 100,000/mm
- Patient must not be pregnant or breastfeeding
- No uncontrolled infections
- No significant traumatic injury within the past 3 months
- No uncontrolled seizure disorders
- Patients must be >18 years old
- No unstable brain metastasis
- No major surgery in the past 1 month
- Patients must agree not to use herbal remedies during the phase of the clinical trial
- Patient must be able to swallow capsules or tablets
- Willingness to have multiple blood draws

Clinical Trial Phases

All lung cancer clinical trials are divided into trial phases ranging from I to III. Here is a look at each trial phase.

i) Phase I

The primary purpose of a Phase 1 clinical trial is to determine the effectiveness of a specific drug, how it reacts when given to the patient and appromixate dose to be used in future clinical trials. Phase I trials are limited to a maximum of 30 people divided into groups of 3 to 6. Each individual group is treated with increasing doses of the drug. For example, the first 6 people may receive a pre-clinical dose with low effects. If no serious side effects are found, the second group will receive a higher dose of the drug. The time lap between these two stages is 3-4 weeks. This process is repeated until a percentage of participants experience side effects such that it wouldn't make sense to increase the dose of the drug any further. In order to enroll in Phase I clinical trials, patients must have malignant mesothelioma or a type of lung cancer that is related to mesothelioma. The patients must have a life expectancy of minimum 1-2 months and organs that are capable of metabolizing and excreting the drug from the body. Above is an image of a Phase I clinical trial center called the Richmond Pharmacology Center located in Cranmer Terrace, Tooting, London.

ii) Phase II

Phase II clinical trials enroll about 100 or less patients and are strictly designed to evaluate the effectiveness of the drug being studied as well as safety. Phase II clinical trials are particularly effective for types of lung cancer for which there is no known treatment out there, mesothelioma lung cancer is an example. If the drug does appear to be effective, it is sent for additional testing before more patients are injected with the drug. Phase II participants are divided into 2 groups; i) an investigational group which is given a dose of the drug and ii) a standard group that is also given a dose of the drug. None of the participants can select which group they are placed into and the group with the most favourable result will proceed to Phase III trials.

iii) Phase III

Phase III mesothelioma lung cancer clinical trials occur at many major Cancer centers across the US and involve a group of more than 100 participants. The purpose of Phase III trials is to see whether the drug being investigated is better than the drugs currently available on the market. Drugs in Phase III clinical trials are tested to see if they improve quality of life for the patients as well as life expectancy. If the drug being tested is confirmed as safe and effective, the patients on the clinical trial will be the first ones to receive treatment; which is advantageous. However, not all new drugs live up to their standards, some drugs may prove as effective when they are first released, but fail after. Patients should weigh the benefits versus risks of taking such treatments.

Current Cancer Clinical Trials

> Phase I Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer

> Phase I Study of Gene Therapy for Pleural Malignancies

> Phase I Study of FR901228 (Depsipeptide) and Flavopiridol in Patients With Advanced Lung or Esophageal Cancer, Malignant Pleural Mesothelioma, or Lung or Pleural Metastases

> Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Subjects with Pulmonary and Pleural Malignancies

> Phase II Study of Pazopanib Hydrochloride in Patients With Malignant Pleural Mesothelioma

> Phase I Study of Cisplatin, Imatinib Mesylate, and Pemetrexed in Malignant Mesothelioma Patients

> Phase II Randomized Study of Pemetrexed Disodium Combined With Either Gemcitabine or Carboplatin in Patients With Advanced Malignant Mesothelioma of the Pleura

> Phase I Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

> Phase I Study of Anti-Mesothelin Monoclonal Antibody MORAB-009 in Patinets With Recurrent Advanced Mesothelin-Expressing Tumors

> Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

> Phase II Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

> Phase II Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

> Phase I/II Study of Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma

> Phase II Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

> Phase II Study of AZD2171 in Patients With Unresectable Malignant Pleural Mesothelioma

> Phase II Study of PDX101 as Second-Line Therapy in Patients With Unresectable Malignant Pleural Mesothelioma

> Phase II Study of Dasatinib in Patients With Previously Treated Malignant Mesothelioma

> 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

> Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma