Clinical Trials Involving Combination Treatments

Continued from: Mesothelioma Trials

Editor’s Note: The clinical trials listed below are specific to mesothelioma and have participating centers in North America. The website of the National Cancer Institute lists additional mesothelioma trials being conducted abroad, as well as cancer clinical trials that include but are not specific to mesothelioma. For updated information on recruitment for any of the trials discussed in this article, visit clinicaltrials.gov.

Due to the ineffectiveness of single chemotherapy agents for the treatment of mesothelioma, most ongoing clinical trials now focus on evaluating combination treatments. Most of these trials attempt to assess the efficacy of drug therapies, although some involve surgery or other treatment combination modality combinations.

The following are typical strategies used by investigators when selecting combinations of drugs to test in clinical trials for the treatment of mesothelioma.

Different drug classes. Each drug in the combination must individually have at least some anti-tumor activity. Drugs belonging to different classes often have different mechanisms and are therefore more potent and more effective for combination treatment than drugs of the same class. For example, an alkylating agent, such as Platinol, in combination with an antimetabolite agent, such as Alimta, has a synergistic effect for fighting malignant mesothelioma. Using two types of alkylating agents would not be expected to have such a synergistic effect.

Different mechanisms. While using two types of the same agent may not be effective, when drugs within the same class function through different mechanisms, they may work well together. For example, antimetabolite drugs are designed to block the synthesis of DNA by impeding the nutrients and other chemicals needed for DNA metabolism. Two antimetabolite drugs that block different kinds of nutrients may be able to work together in a synergistic manner.

Different toxicity levels. Drugs that have different levels of toxicity dosage may also be 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.

Active Clinical Trials Involving Combination Treatments

The following is a list of ongoing clinical trials involving combination chemotherapy and other types of “combination treatments” for mesothelioma. Click on the links below each trial for updated information on eligibility and recruitment status.

Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients with MPM

This mesothelioma clinical trial will assess the effectiveness of combination therapy involving Carboplatin, Bevacizumab (Avastin) and Pemetrexed (Alimta) in treating patients with malignant pleural mesothelioma (MPM). (Click here to learn more about eligibility and recruitment.)

Study of CBP501 + Pemetrexed + Cisplatin in Patients with Solid Tumors (Phase I) and Patients with Malignant Pleural Mesothelioma (Phase II)

This malignant pleural mesothelioma clinical trial will combine full doses of cisplatin and pemetrexed with escalating doses of CBP501. The study is open to patients with confirmed solid malignant mesothelioma that has spread (metastasized) or is unable to be removed through surgery. (Click here to learn more about eligibility and recruitment.)

Short Neoadjuvant Hemithoracic IMRT for MPM

Though radiation treatment reduces the recurrence of tumors in the area treated by more than 90 percent, most mesothelioma patients treated with radiation succumb to the disease anyway. Researchers have suggested this paradox may occur as a result of tumor cells contaminating adjacent areas during surgery. This study will attempt to determine the effectiveness of sterilizing these cells through short, intense doses of radiation to the chest prior to surgery. (Click here to learn more about eligibility and recruitment.)

Pleurectomy/Decortication with Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin with Sodium Thiosulfate

This mesothelioma trial will assess the viability of administering cisplatin as well as Alimta in patients undergoing surgery with heated cisplatin. (Click here to learn more about eligibility and recruitment.)

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

This malignant mesothelioma clinical trial will attempt to determine the effect of a combination therapy on progression of mesothelioma. The therapy consists of cisplatin, pemetrexed and bevacizumab. (Click here to learn more about eligibility and recruitment.)

Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients with Locally Advanced But Unresectable Malignant Pleural Mesothelioma

For certain types of mesothelioma, radiation therapy is typically not used due to the risk of severe side effects, including lung damage (pneumonitis). A new radiation technique known as intensity-modulated radiation therapy (IMRT) has shown promise in reducing these side effects. This clinical trial will assess the safety of using chemotherapy followed by IMRT. (Click here to learn more about eligibility and recruitment.)

An Efficacy Study of MORAb-009 in Subjects With Pleural Mesothelioma

This malignant pleural mesothelioma clinical trial will attempt to determine whether combination therapy involving cisplatin and pemetrexed is more effective when administered along with an experimental drug called MORAb-009. (Click here to learn more about eligibility and recruitment.)

Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma

This clinical trial will test the response rate of patients treated with chemotherapy involving Oxaliplatin (ELOXATIN) and Gemcitabine. (Click here to learn more about eligibility and recruitment.)

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Current treatments for pleural mesothelioma often lead to reduced lung function, ultimately requiring removal of the lung, which can dramatically affect lung function and quality of life. This clinical trial will attempt to show that measures can be taken to prevent the necessity of lung removal. (Click here to learn more about eligibility and recruitment.)

Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

Investigators in this clinical trial will change the order in which the treatments that make up trimodality therapy (surgery, chemotherapy and radiation) are administered. They believe that treating patients with chemotherapy first, followed by surgery and radiation therapy, may reduce the recurrence of tumors and increase survival times. (Click here to learn more about eligibility and recruitment.)

Decitabine and FR901228 in Treating Patients with Advanced Lung Cancer, Esophageal Cancer, Pleural Mesothelioma, or Lung Metastases

Different chemotherapy drugs attack tumor cells differently; as a result, treatment that involves two different types of chemotherapy drugs may destroy more tumor cells. Investigators in this trial, which focuses on patients with inoperable pleural mesothelioma and other types of cancer, will attempt to determine the best doses of two types of chemotherapy drugs: FR901228 and decitabine. (Click here to learn more about eligibility and recruitment.)

Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

The primary objective of this malignant mesothelioma clinical trial is to determine the maximum tolerable dose of a combination drug therapy comprised of cisplatin, pemetrexed and imatinib mesylate. These drugs attack mesothelioma using three different mechanisms. (Click here to learn more about eligibility and recruitment.)

Immunotoxin Therapy, Pemetrexed, and Cisplatin in Treating Patients with Malignant Pleural Mesothelioma that Cannot Be Removed by Surgery

This mesothelioma clinical trial will study the best dosage and the side effects of a mesothelioma combination treatment consisting of two chemotherapy drugs (cisplatin and pemetrexed) plus immunotoxin therapy, in combination with one another. Each component of the therapy attacks cancer cells in a different manner. (Click here to learn more about eligibility and recruitment.)

Phase I Dose-Escalation Study of Azacitidine in Combination with Temozolomide

This “dose-escalation” clinical trial will attempt to assess the safety and toxicity of a combination drug therapy (Temozolomide and Azacititine) used to treat mesothelioma and advanced soft tissue sarcoma. (Click here to learn more about eligibility and recruitment.)

Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine with Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Following removal of pleural mesothelioma tumors, chemotherapy is used to kill tumor cells and stop them from dividing. This malignant pleural mesothelioma clinical trial will attempt to determine the safety of adding gemcitabine to the chemotherapy treatment. In addition, two “cytoprotection agents” will be used in an attempt to counter any potential side effects. (Click here to learn more about eligibility and recruitment.)

See Also:
» Treatments Under Investigation

[Page updated September 2009]