Mesothelioma Clinical Trials
A mesothelioma diagnosis is a serious one, but it is not one without hope. There are a variety of treatments available, and a number of ongoing clinical trails.
Trial Status
We do our best to keep the current status (closed, currently recruiting, upcoming) of each clinical trial up-to-date. Several clinical trials are listed at ClinicalTrials.gov as "currently recruiting" despite the estimated completion date having been long past. The contact for a particular clinical trial is your best bet to discover if a particular clinical trial is still open and recruiting.
Glossary
To help you as you read through these clinical trials, we have glossary of terms and their definitions. Words underlined with a dashed line are part of the glossary; to see their definition, simply click on the word.
Clinical Trials
Purpose:
- Background:
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- Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body’s internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for all kinds of mesothelioma, so researchers are searching for new ways to treat it.
- Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how safe and effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.
- Objectives:
- To study the safety and effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.
- Eligibility:
- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.
- Design:
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- Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
- The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
- In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
- On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
- Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
- Participants will have regular followup visits as directed by the study doctors….
Purpose: The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma
- Arm A: NGR-hTNF + Best Supportive Care: Experimental
- Interventions:
- Drug: NGR-hTNF. NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
- Other: Best Supportive Care. Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
- Arm B: Placebo + Best Supportive Care: Placebo Comparator
- Interventions:
- Drug: Placebo. Placebo: 0.8 mcg/m2 as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
- Other: Best Supportive Care. Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
Purpose: The aim of this study is to learn about how mesothelioma affects patients’ emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home.
- Surgical group with mesothelioma: Behavioral: Questionnaires & online virtual support group
- The study proposed here has two parts:
- Part 1 surveys mesothelioma patients’ psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based support group.
- In part 2, patients are invited to participate in an Internet-based support group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
- Non Surgical group with mesothelioma: Behavioral: Questionnaires & online virtual support group
- The study proposed here has two parts:
- Part 1 surveys mesothelioma patients’ psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based support group.
- In part 2, patients are invited to participate in an Internet-based support group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
Purpose: To determine the safety and manufacturing feasibility of IV autologous chimeric immune receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor domain and the 4-1BB costimulatory domain.
- Cohort 1 – One dose of cells: Experimental
- Intervention: Biological: Autologous T cells
- Cohort 2 – three doses of cells: Experimental
- Intervention: Biological: Autologous T cells
Purpose: The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons’ decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.
Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.
The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.
Purpose:
This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
- Arm: Treatment (cryoablation): Experimental. Patients undergo CT-guided CA.
- Interventions:
- Procedure: cryotherapy
- Procedure: quality-of-life assessment
Purpose: This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.
- Arm 1: Cisplatin with pemetrexed: Active Comparator; Intervention: Procedure: Gemcitabine in long infusion
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- Procedure: Gemcitabine in long infusion
- TREATMENT A:
- Day 1: Pemetrexed 500 mg/m2 Cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: folic acid [Tifol 400 mg tbl (350-1000 mg), beginning 7 days before CT, every day, till 3 week after the KT], vitamin B-12 [OH-B12 i.m., beginning in 7 days before CT, than at 3. + 6. cycles of KT + 9. week after the KT], corticosteroids, hydration, antiemetic, LMW heparin as thromboprophylaxis.
- In the absence of progression, 4 cycles of chemotherapy with pemetrexed and cisplatin will be given, followed by two additional cycles of pemetrexed as monotherapy.
- TREATMENT B:
- TREATMENT A:
- Days 1 and 8: gemcitabine 250 mg/m2 in 6 hours day 2: cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: corticosteroids, hydration, antiemetics, LMW heparin as thromboprophylaxis.
- In the absence of progression, 4 cycles of chemotherapy with gemcitabine and cisplatin will be given, followed by two additional cycles of gemcitabine alone as monotherapy.
- Procedure: Gemcitabine in long infusion
- Arm 2: Cisplatin with gemcitabine in long infusion: Experimental; Intervention: Procedure: Gemcitabine in long infusion
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- Procedure: Gemcitabine in long infusion
- TREATMENT A:
- Day 1: Pemetrexed 500 mg/m2 Cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: folic acid [Tifol 400 mg tbl (350-1000 mg), beginning 7 days before CT, every day, till 3 week after the KT], vitamin B-12 [OH-B12 i.m., beginning in 7 days before CT, than at 3. + 6. cycles of KT + 9. week after the KT], corticosteroids, hydration, antiemetic, LMW heparin as thromboprophylaxis.
- In the absence of progression, 4 cycles of chemotherapy with pemetrexed and cisplatin will be given, followed by two additional cycles of pemetrexed as monotherapy.
- TREATMENT B:
- Days 1 and 8: gemcitabine 250 mg/m2 in 6 hours day 2: cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: corticosteroids, hydration, antiemetics, LMW heparin as thromboprophylaxis.
- In the absence of progression, 4 cycles of chemotherapy with gemcitabine and cisplatin will be given, followed by two additional cycles of gemcitabine alone as monotherapy.
- TREATMENT A:
- Procedure: Gemcitabine in long infusion
Purpose: To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted therapy in patients with ASS-negative malignant pleural mesothelioma.
- Arm A: No Intervention
- Arm A is control arm with best supportive care.
- Arm B: Experimental
- Arm B is the treatment arm with best supportive care plus ADI-PEG20.
- Intervention: Drug: ADI-PEG 20. Drug: ADI-PEG 20. 36.8mg/m2 based on BSA, weekly treatment for 6 months
Purpose: The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or
prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer
cells that regulates gene expression and causes cell growth. Mesothelioma tumors
generally have high levels of WT1. The patient will be assigned to one of two treatment
groups. One group will receive non-specific immunotherapy with medications called
Montanide and Sargramostim (GM-CSF). The other group will receive more specific
immunotherapy with the WT1 vaccine plus Montanide and GM-CSF. Both Montanide and GM-CSF
are commonly given along with vaccines because they have a general effect in boosting
the immune response. Some researchers believe that this general increase in the immune
system may have some effect in treating cancer. Some studies using GM-CSF with melanoma
vaccines have suggested that it could lessen the effects of the vaccine. The addition
of the WT1 proteins makes this therapy more directed to mesothelioma. The combination
of WT1 vaccine with Montanide and GM-CSF has been tested in a prior trial including 9
patients with advanced mesothelioma. In that trial, the vaccine was safe and caused an
immune response. The patient will have a 50% chance of being in each group. Neither the
patient nor the doctor will be aware of which group they are in.
- Arm: WT-1-vaccine Montanide + GM-CSF: Experimental
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- The study will be a randomized phase II trial to determine the 1-year
progression free survival after treatment with WT-1 analog peptide vaccine
in patients with MPM after completion of combined modality therapy. - Intervention: Biological: WT-1-vaccine Montanide + GM-CSF
- The study will be a randomized phase II trial to determine the 1-year
- Assigned Interventions: Biological: WT-1-vaccine Montanide + GM-CSF
- Patients will receive 6 injections over 12 weeks. Treatment will be
administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive
Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of
each vaccination. Patients may self administer the Sargramostim (GM-CSF) on
day -2 if they have been appropriately instructed on SQ injection
administration. Patients will keep a logbook noting the time and placement
of the injection. Patients will also receive 1.0 ml of emulsion with
Montanide alone or with WT-1 peptides plus Montanide. It will be
administered subcutaneously to the same anatomical site as the GM-CSF. This
site will be marked by the patient or treating healthcare professional by a
permanent marker pen.
- Patients will receive 6 injections over 12 weeks. Treatment will be
- Arm: Montanide adjuvant + GM-CSF: Active Comparator
-
- The study will be a randomized phase II trial to determine the 1-year
progression free survival after treatment with WT-1 analog peptide vaccine
in patients with MPM after completion of combined modality therapy. - Intervention: Biological: Montanide adjuvant + GM-CSF
- The study will be a randomized phase II trial to determine the 1-year
- Assigned Interventions: Biological: Montanide adjuvant + GM-CSF
-
- Patients will receive 6 injections over 12 weeks. Treatment will be
administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive
Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of
each vaccination. Patients may self administer the Sargramostim (GM-CSF) on
day -2 if they have been appropriately instructed on SQ injection
administration. Patients will keep a logbook noting the time and placement
of the injection. Patients will also receive 1.0 ml of emulsion with
Montanide alone or with WT-1 peptides plus Montanide. It will be
administered subcutaneously to the same anatomical site as the GM-CSF. This
site will be marked by the patient or treating healthcare professional by a
permanent marker pen.
- Patients will receive 6 injections over 12 weeks. Treatment will be
Background: Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient’s tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX™, which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX™ has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body’s immune reaction if given with the vaccine.
Objectives: To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX™ and celecoxib in the treatment of lung and esophagus cancers.
