Pleural Malignancies And Gene Therapy
The gene therapy for Pleural malignancies is a phase I Clinical trial which is in the active status with the Protocol IDs- 803776, UPCC 03505, NCT00299962.
The objective of the trial is to determine the safety of the drug BG00001 when it is applied in two doses. Persons suffering from malignant pleural mesothelioma or from pleural effusions are chosen as the subjects of the study. It is also required that the persons must have undergone at least one prior therapy or have refused a therapy at all. BG00001 is given to the patients twice. The first dose is given on the Ist day and the second dose on the 15th day. The drug is pushed through a catheter into the pleural space.
BG00001 is a replication-defective recombinant adenoviral vector that contains the human interferon-beta (hIFN-β) gene. This Clinical Trial is used to determine the safety of the drug as well as to note the maximum dose that be tolerated by the subjects (metastatic or pleural mesothelioma patients) receiving dual doses of intrapleural (IP) BG00001, the other name of which is Ad.hIFN-β.
The eligibility criteria include a pathological proof regarding the conformation of pleural effusions because of malignant mesothelioma. The ECOG performance status should be zero or one. The pleural space, which contains the tumor, must be accessible with a pleural catheter. The FEV1 should be greater than one liter or 40 percent of the estimated value. It is also required that the patients had received a past treatment with radiotherapy, chemotherapy, or immunologic agents four weeks before the dosage of BG00001 are given to them.
Presence of brain metastases, simultaneous use of immunosuppressant and systemic steroids, and malignant pleural effusions that are secondary to lymphoma are some of the exclusion criteria. Patients with rapidly re- accumulating pleural effusions are also excluded from being the subjects.
The sponsor is Abramson Cancer Center of the University of Pennsylvania and for further information; one might give a call at 215-573-6760.