Lung Cancer

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

A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies

Purpose: The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, docetaxel, or pemetrexed.

Experimental; Arm A: HGS1036 + Paclitaxel + Carboplatin
Drug: HGS1036 + Paclitaxel + Carboplatin
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg∙min/mL, IV every 3 weeks on Day 1 of each 21-day cycle.
Experimental; Arm B:
HGS1036 + Cisplatin + Etoposide
Drug: HGS1036 + Cisplatin + Etoposide
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle.
Experimental; Arm C:
HGS1036 + Docetaxel
Drug: HGS1036 + Docetaxel
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle.
Experimental; Arm D:
HGS1036 + Pemetrexed
Drug: HGS1036 + Pemetrexed
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle.

Read More »

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

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.

Read More »

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

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.

Read More »

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, 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:
Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status, Upcoming
Tags:
Comments:
0

Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)

Purpose: Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen). Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma. This is most commonly caused by exposure to asbestos.

Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is based around controlling the disease and managing the symptoms, rather than curing the disease.

The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two anticancer drugs; Pemetrexed and Cisplatin.

The trial will look into whether there are benefits of adding a third drug called Vorinostat to the treatment.

Phase II only – Arm I: Active Comparator
If the patient is randomised into the Vorinostat arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle plus the dose of Vorinostat determined in the phase I study.
Interventions:

  • Drug: Cisplatin.
    Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles
  • Drug: Pemetrexed.
    Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles
  • Drug: Vorinostat.
    The dose and frequency of vorinostat will be determined in the Phase I study. Vorinostat will be given concurrently with Cisplatin/Pemetrexed.
Phase II only – Arm 2: Placebo Comparator
If the patient is randomised into the placebo arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle with the placebo for the same number of days as in the vorinostat arm.
Interventions:

  • Drug: Cisplatin.
    Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles
  • Drug: Pemetrexed.
    Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles
  • Drug: Placebo.
    Patients randomised into the placebo arm of the trial will receive Cisplatin and Pemetrexed as standard as well as placebo.

Read More »

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

Cryotherapy in Treating Patients With Lung Cancer

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

Read More »

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

Tumor Cell Vaccines With ISCOMATRIX(Trademark) Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

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.

Read More »

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

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Purpose: Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.

Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.

We propose to conduct a study to determine how well water soluble iodinated contrast material when injected directly into the tumor can be visualized on CT scan and integrated into radiation therapy treatment planning.

Read More »

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

Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas

Background:
Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer.
Objectives:

To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest.
Eligibility:
Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma.
Design:
  • Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing.
  • Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine.
  • Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib.
  • One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines.
  • Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.

Read More »