Mesothelioma

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Randomized Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy

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
  • 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
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.
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
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.

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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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.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

Purpose: This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

arm 1: Dose Level 1: Experimental
Biological: SCH 721015
1.0 x 10e12 viral particles on Days 1 and 4
arm 2: Dose Level 2: Experimental (This is a dose de escalation)
Biological: SCH 721015
3.0 x 10e11 viral particles on Days 1 and 4

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Axitinib in Malignant Mesothelioma (N08CPA)

Purpose: The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma.

arm 1: Active Comparator: cisplatin + premetrexed
Drug: chemotherapy
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
arm 2: Experimental: axitinib + cisplatin + premetrexed
Biological: axitinib
axitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

Purpose: The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

Arms

Experimental: infusion of zoledronic acid
Zoledronic acid will be administered on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Drug: Zometa (zoledronic acid): Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

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Clinical Trials, Lung Cancer, Mesothelioma, Status, Terminated
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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.

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Clinical Trials, Mesothelioma, Peritoneal Mesothelioma, Recruiting, Status
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Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Purpose: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Background:
IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.
Objectives:
To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
Eligibility:
Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
Design:
  • * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies.
  • * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed.
  • * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.

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Clinical Trials, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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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.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma (PMR-MM-002)

Purpose: Earlier the investigators determined the safety and feasibility of tumor lysate-pulsed dendritic cells as therapeutic adjuvants in mesothelioma patients. Because pre-clinical data in mice had shown that better results were obtained when regulatory T cells were depleted using low-dosis of cyclophosphamide, ten patients who responded on chemotherapy are selected for DC-treatment in combination with Endoxan.

DC immunotherapy + CTX: Experimental
Patients with mesothelioma who are fit enough to be treated with chemotherapy and enough tumor material was available are asked for participation in this study. After 4 cycles of Alimta chemotherapy, a leukapheresis is performed of which the monocytes are used for differentiation to DCs using different cytokines. The procedure to grow DCs in vitro and pulse them with tumor lysate is performed according to our earlier performed phase I study that was approved by our local ethics committee. Three doses of properly pulsed autologous DCs (MesoCancerVac) are then re-injected every two weeks. Patients will be treated with a low dose of CTX for seven day in a row the week before the 1st vaccination, the weeks in between the 2nd, and for one week after the 3rd vaccination.
Intervention: Biological: DC + CTX
3x 50x10e6 DC + cyclophosphamide
Other Name: Endoxan

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