Clinical Trials

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)

Purpose: Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos.

Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath.

Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.

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Clinical Trials, Closed, Mesothelioma, Status
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Treating Cancer With Anti-mesothelin Modified Lymphocytes

Background:
A possible new procedure for treating people with advanced cancer uses blood cells known as peripheral blood cells. Once these cells are modified and grown in a laboratory, they can be used to target and destroy cancer cells. Some cells can be modified to target a protein called mesothelin that is found on some types of cancer cells. By blocking mesothelin, it is expected that these cells will help shrink existing tumors. However, it is possible that the cells will not have this effect. Researchers want to try this therapy on people who have advanced cancer that has not responded to standard treatments.
Objectives:
To test the safety and effectiveness of anti-mesothelin modified cells for advanced cancer.
Eligibility:
Individuals at least 18 years of age with advanced cancer that involves mesothelin and has not responded to standard treatments.
Design:
  • Participants will be screened with a physical exam and medical history. They will also have imaging studies before starting treatment. Blood and urine samples will be collected.
  • Participants will have leukapheresis to collect peripheral blood cells. These cells will be modified for the treatment.
  • Participants will have chemotherapy to prepare the immune system to receive the modified cells. The chemotherapy will take place for 1 week before the cell infusion.
  • Participants will receive their modified cells as an infusion. They will also receive interleukin-2 to help boost their immune system response. The interleukin-2 will be given every 8 hours for up to 15 doses.
  • Participants will recover from the infusion treatment in the hospital for at least 2 weeks.
  • The results of the treatment will be monitored with frequent follow-up blood tests and imaging studies.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)

Purpose: This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy.

We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person’s immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.

Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone.

Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.

Arms: Experimental: TroVax®
In this single-arm study, all participants will receive 9 injections of the TroVax® vaccine, plus standard cisplatin and pemetrexed chemotherapy.
Interventions
Biological: TroVax®: Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.
Drug: Pemetrexed
500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.
Drug: Cisplatin
75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13
Dietary Supplement: Vitamin B12
1000μg intramuscular, Day 2 of weeks 3 and 12
Dietary Supplement: Folic Acid
400μg oral daily from Day 2 of week 3 to Day 2 of week 16
Drug: Dexamethasone
4mg BD, Days 2-6 of weeks 4, 7, 10, 13

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
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A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies

Purpose: The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.

Arm: Experimental: Combination therapy with OSI and Pemetrexed
Drug: OSI-906 and Pemetrexed
Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability.
OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
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A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Purpose This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.

Arms: Experimental: Amatuximab infusion
Assigned Interventions

  • Drug: Amatuximab: Subjects will receive one low dose (50mg) infusion of amatuximab followed by an infusion of radiolabeled amatuximab.
  • Other Names:
    • MORAb-009
    • MORAB-009-006

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Clinical Trials, Closed, Mesothelioma, Mesothelioma of the Tunica Vaginalis, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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BAY 94-9343 for Advanced Solid Tumors

Purpose:

Background:
Mesothelin is a protein on the lining of the lungs, heart, and abdomen. It is often present at higher levels on some cancer cells. Anticancer drugs given directly to cells with high mesothelin levels may help destroy the cancer cells with fewer effects on healthy cells. BAY 94-9343 combines an anticancer drug with a type of protein that targets mesothelin. Researchers want to see if BAY 94-9343 can treat advanced cancers that have mesothelin on the cells.
Objectives:
To test the safety and effectiveness of BAY 94-9343 on advanced solid tumors.
Eligibility:
Individuals at least 18 years of age who have advanced solid tumors that have mesothelin on the cells.
Design:
  • Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and imaging studies. Heart and lung function tests and an eye exam will also be included.
  • The study drug will be given in 3-week cycles of treatment. At the start of each cycle, participants will have BAY 94-9343 as an infusion for about 1 hour.
  • Treatment will be monitored with frequent blood tests, heart and lung function tests, and imaging studies. Treatment will continue as long as the tumor does not start growing and no severe side effects develop.

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Study of ABT-700 in Subjects With Advanced Solid Tumors

Purpose: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Approximately 51 to 75 subjects will be enrolled.

Arms
  • Cohort A: Experimental
    • ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
    • Intervention: Drug: ABT-700
  • Cohort B: Experimental
    • ABT-700 plus erlotinib 150 mg qd (21-day cycle).
    • Intervention: Drug: ABT-700 plus erlotinib
  • Cohort C: Experimental
    • ABT-700 plus oxaliplatin and capecitabine. ABT-700 IV (Day 1) Oxaliplatin: 130 mg/m2 IV (Day 1) Capecitabine: 1000 mg/m2 Oral (twice daily Days 1 – 14).
    • Intervention: Drug: ABT-700 plus Oxaliplatin and Capecitabine

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma

Purpose:

Background:
Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen.
SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells.
Objectives:
To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients’ tumors.
To learn how the body breaks down SS1(dsFV)PE38.
Eligibility:
Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
Design:
Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:
  • Day 1 – Intravenous (through a vein) infusions of pemetrexed and cisplatin.
  • Days 1 and 2 – Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38.
  • Days 1, 3 and 5 – Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined.
Continuing standard treatment with additional cycles of pemetrexed and cisplatin.
Evaluations during the treatment period:
  • Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
  • Questions about medications and side effects.
  • Blood and urine tests.
  • Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires.
Post-treatment evaluations:
  • Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment.
  • End-of-study visit for bl…

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Clinical Trials, Mesothelioma, Status, Terminated
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Amatuximab for High Mesothelin Cancers

Purpose:

Background:
Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
Objectives:
To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.
Eligibility:
Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.
Design:
  • Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
  • Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
  • Participants will have a third imaging study of the cancer about 1 week after the infusions.
  • Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients’ symptoms or side effects. This interview can be done in person or by phone….

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