Closed

Date:
Categories:
Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
Tags:
Comments:
0

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Mesothelioma of the Tunica Vaginalis, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

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.

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Lung Cancer, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Advanced Lung and Non-colorectal Gastrointestinal Malignancies

Purpose: The main purpose of this study is to compare two types of care – standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients’ and caregivers’ quality of life, mood, coping and understanding of their illness.

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Purpose:

Background:
  • 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:
  • 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….

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Status
Tags:
Comments:
0

Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (NGR019)

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma

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.

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

Autologous Redirected RNA Meso-CIR T Cells

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

Read More »