Clinical
Trials for Mesothelioma Lung Cancer - Basic Info, Trial Phases,
Eligibility & Current Clinical Trials
(August 14th, 2008)
 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
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