Combining Treatments and Clinical Trials

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» ONCONASE Clinical Trial
» Radiation Therapy Clinical Trial
» Active Symptom Control Clinical Trial
» Alimta plus Gemcitabine Clinical Trial
» Advanced Malignant Pleural Mesothelioma Clinical Trial
» Chemotherapy and Tamoxifen Clinical Trial

Due to the poor effectiveness of single chemotherapy agents for the treatment of mesothelioma, most ongoing clinical trials are now evaluating combination treatments. The following are typical principles that are used when selecting combinations of drugs to test in clinical trials for the treatment of mesothelioma.

Each drug in the combination must individually have at least some anti-tumor activity. Drugs that act by different mechanisms make for higher potency and more effective for combination treatment than drugs of the same class. For example, an alkylating agent, such as Platinol, in combination with an antimetobolite agent, such as Alimta, provides a synergistic affect for the fighting malignant mesothelioma.

Using two types of alkylating agents would not be expected to have such a synergistic affect. However, when drugs within the same class function through different mechanisms, these can also have synergistic effects. For example, antimetabolite drugs are designed to block the synthesis of DNA by impeding the nutrients and other chemicals needed for DNA metabolism. If different drugs block different kinds of nutrients, then these drugs may be able to work together in a synergistic way

Drugs that have different levels of toxicity dosage are also typically evaluated for combination therapy. Drug combinations that can be given intermittently allow time for the patient to recover from the short-term side effects of the treatment.

The following describes a number of the ongoing clinical trials evaluating combination chemotherapy, as well as other types of treatments for mesothelioma:

ONCONASE Clinical Trial - ONCONASE plus Doxorubicin vs. Doxorubicin alone for patients with malignant pleural or peritoneal mesothelioma who have had no more than one prior chemotherapy regimen.

This is a Phase III clinical trial where a new drug, ONCONASE, is being tested in combination with Doxorubicin for the treatment of malignant mesothelioma. Doxorubicin is an older cancer drug that is considered an antibiotic and directly damages DNA cells through free radical damage.

ONCONASE is a potentially exciting new drug for cancer treatment because it uses a relatively new type of action to stop the spread of mesothelioma cancer cells. It has been proposed that ONCONASE functions to stop damaged cells from recovery. Cancer cells, just like any other cells in the body, have a means to heal after they have been damaged. Consequently, when a drug such as Doxorubicin damages a cancer cell, ONCONASE potentially blocks the cancer cells from healing themselves and forces the cancers cells to die from the damage.

This process would provide for the elimination of the cancer cells in a shorter time period. It is hoped that these two drugs would have such a synergistic affect. (Click here to learn more about eligibility and details for the clinical trial.)

Radiation Therapy Clinical Trial - Radiation therapy in preventing metastatic cancer in patients who have diagnostic procedures to identify malignant mesothelioma.

This is a Phase III clinical trial to investigate the use of radiation therapy to prevent the development of skin nodules that occur in conjunction with procedures used to diagnose mesothelioma. (Click here to learn more about eligibility and details for the clinical trial.)

Active Symptom Control Clinical Trial - Active symptom control with or without chemotherapy in treating patients with malignant pleural mesothelioma.

This is a Phase III clinical trial evaluating the active symptom control when patients have or have not been treated with chemotherapy. (Click here to learn more about eligibility and details for the clinical trial.)

Alimta plus Gemcitabine Clinical Trial - Alimta (pemetrexed) plus Gemcitabine (Gemzar) for patients with malignant pleural or peritoneal mesothelioma who have not had previous chemotherapy.

This is a Phase II clinical trial to evaluate the use of Alimta and Gemcitabine for the treatment of malignant pleural mesothelioma or peritoneal mesothelioma. Both of the drugs interfere with the growth of cancer cells by blocking the DNA synthesis. These drugs are known as antimetabolites and work through blocking the enzymes, nutrients and other substances needed by the cells for metabolism.

The purposes of the study are to:

Study the safety and side effects when Alimta and Gemitabine are used together
Determine if this combination of drugs allows mesothelioma patients to live longer
Determine whether this drug combination can shrink or stop the growth of mesothelioma tumors
Determine if patients have a better quality of life and “feel” better taking this drug combination

(Click here to learn more about eligibility and details for the clinical trial.)

Advanced Malignant Pleural Mesothelioma Clinical Trial - Pemetrexed Disodium and Either Gemcitabine or Carboplantin in treating patients with advanced malignant pleural mesothelioma.

This is a Phase II clinical trial to evaluate the use of Alimta (pemetrexed disodium) and either Gemcitabine or Carboplantin in treating mesothelioma patients. Both Alimta and Gemcitabine are antimetabolic agents that block cancer cell growth by not allowing the metabolism process in the cell DNA. Carboplantin is a platinum compound that directly damages cancer cell DNA through alkylation. This study will determine if the different types of drugs work better in combination to slow or stop the progression of mesothelioma. (Click here to learn more about eligibility and details for the clinical trial.)

Chemotherapy and Tamoxifen Clinical Trial - Combination chemotherapy and Tamoxifen in treating patients with solid tumors.

This is a Phase II clinical trial comparing cisplantin (an alkylating agent), doxorubicin (an antibiotic) and tamoxifen (anti-estrogen agent) for the treatment of patients with incurable cancers, including malignant mesothelioma. (Click here to learn more about eligibility and details for the clinical trial.)

For more information about other Phase II clinical trials, click here.

See Also:
» Treatments Under Investigation

[Page updated March 2006]