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Phase I
Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With MPM
Phase I, Phase II
Location:
Tampa, FL: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Trial Summary:
The purpose of this research study is to evaluate how effective the combination of Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is considered standard for this disease and typically off protocol patients would receive cisplatin or carboplatin and pemetrexed as standard of care.
Contact Information:
Melissa Joiner, R.N. Ph: 813-745-1896
Email: .(JavaScript must be enabled to view this email address)
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Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II)
Phase I, Phase II
Location:
Multiple Locations
Trial Summary:
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial. The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
Contact Information:
Please see additional information.
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Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer
Phase I, Phase II
Location:
New York, New York: Memorial Sloan-Kettering Cancer Center
Trial Summary:
The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation and to see whether this method is more effective than the standard method of using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT scanner attached to the treatment accelerator that produces 3D images of the patient.
Contact Information:
Kenneth Rosenzweig, MD
Email: .(JavaScript must be enabled to view this email address)
Gikas Mageras, PhD
Email: .(JavaScript must be enabled to view this email address)
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Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Subjects with Pulmonary and Pleural Malignancies
Phase I
Location:
Bethesda, MD: NCI - Center for Cancer Research
Trial Summary:
- Determine the pharmacokinetics, toxicity, and maximum tolerated dose of decitabine and FR901228 (depsipeptide) in patients with unresectable pulmonary, esophageal, or pleural malignancies.
- Determine serologic response to NY-ESO-1 in these patients before and after receiving this regimen.
- Evaluate apoptosis in tumor biopsies of these patients before and after receiving this regimen.
Contact Information:
Tricia Kunst, RN
|
Ph: |
301-451-1233 |
Email: .(JavaScript must be enabled to view this email address)
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Phase I Study of FR901228 (Depsipeptide) and Flavopiridol in Patients With Advanced Primary Lung or Esophageal Cancer, Malignant Pleural Mesothelioma, or Lung or Pleural Metastases
Phase I
Location:
Bethesda, MD: NCI - Center for Cancer Research
Trial Summary:
- Determine the maximum tolerated dose and dose-limiting toxic effects of FR901228 (depsipeptide) when administered with flavopiridol in patients with advanced primary lung or esophageal cancer, malignant pleural mesothelioma, or lung or pleural metastases.
- Determine the pharmacokinetics of this regimen in these patients.
Contact Information:
Tricia Kunst, RN
|
Ph: |
301-451-1233 |
Email: .(JavaScript must be enabled to view this email address)
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Gene Therapy for Pleural Malignancies
Phase I
Location:
Philadelphia, PA: Abramson Cancer Center of the University of Pennsylvania
Trial Summary:
This Phase I study will evaluate the safety of two doses of BG00001. Eligible subjects will have malignant pleural mesothelioma, or pleural effusions who have progressed through at least one prior therapy or have refused therapy.
Contact Information:
Adri Recio, RN
Ph: 215-573-6760
Email: .(JavaScript must be enabled to view this email address)
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Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
Phase I
Location:
Houston, TX: M. D. Anderson Cancer Center at University of Texas
Trial Summary:
The primary objective of this trial is to determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.
Contact Information:
Anne S. Tsao, MDPh: 713-792-6363
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Phase I Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
Phase I
Location:
Philadelphia, PA: Kimmel Cancer Center at Thomas Jefferson University – Philadelphia
Trial Summary:
This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure. The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.
Contact Information:
Adam P Dicker, Md, PhD
Ph: 215-955-6527
Email: .(JavaScript must be enabled to view this email address)
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Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
Phase I
Location:
Houston, TX: M. D. Anderson Cancer Center at University of Texas
Trial Summary:
The primary objective of this trial is to establish acceptable dosages of paclitaxel, oxaliplatin and bevacizumab in a regimen of intravenous bevacizumab followed by continuous intravenous infusion of paclitaxel on day 1, intraperitoneal oxaliplatin on day 2, and intraperitoneal paclitaxel on day 8 once every 3 weeks in patients with advanced peritoneal carcinomatosis.
Contact Information:
Apostolia Tsimberidou, MD, PhD
Ph: 713-792-4259
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A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
Phase I
Location:
Aurora, CO: Pfizer Incorporated
Trial Summary:
This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.
Contact Information:
Pfizer Oncology Clinical Trial Information Service
Ph: 1-877-369-9753
Email: .(JavaScript must be enabled to view this email address)
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Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Combination With Pemetrexed Disodium and Cisplatin in Patients With Unresectable Malignant Epithelial Pleural Mesothelioma
Phase I
Location:
Bethesda, MD: NCI - Center for Cancer Research
Trial Summary:
Primary Objectives:
- To estimate the maximum tolerated dose (MTD) of SS1(dsFv)-PE38 immunotoxin when administered with pemetrexed disodium and cisplatin and to establish a safe dose, based on the MTD for subsequent clinical testing (phase II recommended dose) in patients with unresectable malignant epithelial pleural mesothelioma.
- To characterize the toxicity profile of SS1(dsFv)-PE38 immunotoxin.
- To study the clinical pharmacology (i.e., pharmacokinetics) which may dictate modification of SS1(dsFv)-PE38 immunotoxin schedule and administration in future studies.
- To observe antitumor activity, if any, especially in patients who receive SS1(dsFv)-PE38 immunotoxin at or near the MTD (or phase II recommended dose).
Contact Information:
Raffit Hassan, MD, Principal investigator
Ph: 301-451-8742
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Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
Phase I
Location:
New York, NY: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Trial Summary:
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
Contact Information:
Lilian Batista, BS
Ph: 212-305-6837
Email: .(JavaScript must be enabled to view this email address)
Pamela Pujols, BS
Ph: 212-305-1923
Email: .(JavaScript must be enabled to view this email address)
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Phase I Study of Sorafenib Tosylate, Pemetrexed Disodium, and Cisplatin in Patients With Advanced Solid Tumors
Phase I
Location:
Minneapolis, MN: Masonic Cancer Center at University of Minnesota
Trial Summary:
Primary Objectives:
- To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.
Contact Information:
Clinical Trials Office - Masonic Cancer Center at University of Minnesota
Ph: 612-624-2620
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Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma
Phase I
Location:
Boston, MA: Dana-Farber/Brigham and Women's Cancer Center
Trial Summary:
This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.
Contact Information:
David Sugarbaker, M.D.
Ph: 617-732-5004
Email: .(JavaScript must be enabled to view this email address)
Tamara Tilleman, M.D, PhD
Ph: 617-732-5079
Email: .(JavaScript must be enabled to view this email address)
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Dasatinib in Resectable Malignant Pleural Mesothelioma
Phase I
Location:
Houston, TX: M. D. Anderson Cancer Center at University of Texas
Trial Summary:
The primary objective of this novel phase I trial will be the level of biomarker modulation of p-Src Tyr 419 by induction dasatinib therapy in patients with resectable malignant pleural mesothelioma. Secondary objectives include overall and progression-free survival, tumor radiographic and pathologic response, and safety-toxicity profiles. Exploratory analyses will include additional biomarker evaluation in pre- and post-treatment tumor specimens, and serum/platelet/pleural effusion biomarker modulation.
Contact Information:
Anne S. Tsao, MD
Ph: 713-792-6363
For Additional Information, Click Here
Phase I Study of Optical Coherence Tomography of the Airway of Patients Undergoing Pneumonectomy or Lobectomy for Malignant or Benign Lung Processes
Phase I
Location:
Cleveland, OH: Case Comprehensive Cancer Center
Trial Summary:
Objectives:
- Correlate optical coherence tomography images of the airway with airway histology.
- Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
Contact Information:
Jeffrey Kern, MD, Principal investigator
Ph: 216-844-8101; 800-641-2422
For Additional Information, Click Here
Phase I Study of 1-methyl-d-tryptophan in Patients With Relapsed or Refractory Solid Tumors
Phase I
Location:
Nashville, TN: Vanderbilt-Ingram Cancer Center
Trial Summary:
Primary Objectives:
- Establish the toxicities of 1-methyl-d-tryptophan (D-1MT) and define any dose-limiting toxicities if they occur below the maximum doses in patients with relapsed or refractory solid tumors.
- Establish the pharmacokinetics of D-1MT following a single dose and following daily dosing for 7 or 21 days.
- Preliminarily characterize effects of D-1MT on serum kynurenine levels as a biomarker for systemic indoleamine 2,3-dioxygenase activity.
- Define a dose to incorporate into phase II testing based on toxicities, pharmacokinetics, and biologic changes in tryptophan breakdown products.
Contact Information:
Jeffrey Sosman, MD, Principal investigator
Ph: 615-322-4967; 800-811-8480
Email: .(JavaScript must be enabled to view this email address)
For Additional Information, Click Here
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