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Home > "D" Clinical Trials Conditions > Depsipeptide to Treat Lung Cancer  Depsipeptide to Treat Lung Cancer
Depsipeptide to Treat Lung Cancer
For Condition: Lung Neoplasm,Lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the ability of Depsipeptide to shrink or stop the growth of tumors in lung cancer patients. This drug has shrunk tumors in various other kinds of cancers in laboratory and animal studies. Patients with lung cancer who wish to participate in this study will be screened with various tests to determine their eligibility. These include an electrocardiogram (EKG), blood tests, imaging tests (X-rays and scans), lung function tests, and a tumor biopsy. The biopsy-a procedure in which a small sample of tumor is removed-is done in one of two ways, depending on the location of the tumor: 1. The back of the throat is sprayed with a numbing medicine and a bronchoscope (a long flexible tube) is passed down the throat into the lungs to remove the tissue. This procedure is done in the operating room. Or, 2. The skin on the chest is numbed and a thin needle is inserted through the chest to the tumor, where a sample of tissue is taken. This procedure is done in the diagnostic radiology department. Study participants will undergo two 21-day treatment cycles of Depsipeptide. The drug will given in two four-hour infusions-on days one and seven of each cycle-through a catheter (long, thin plastic tube) placed in a vein in the arm or neck or under the collarbone. For each infusion, the patient will be admitted to the hospital for 24 hours. Biopsies will be repeated on day eight of both cycles. Blood samples will be taken several times during the treatment period to evaluate blood levels of the drug and its effects on the body. EKGs will also be done periodically to monitor the heart. Participants have a follow-up evaluation about two weeks after the end of treatment to determine the response to the drug. Tests will include scans of the chest, abdomen, pelvis and brain. Patients whose tumor has shrunk will be offered additional Depsipeptide cycles. This study may provide information that will lead to more effective treatments for lung cancer.
Details: In preclinical studies, we have demonstrated induction of NY-ESO-1 and MAGE-3 cancer testis antigen and p16 tumor suppressor gene expression in lung cancer cells by the demethylating agent, 5 Aza 2' deoxycytidine (Decitabine; DAC), and have commenced a phase I clinical trial to define the MTD of Decitabine and the feasibility of achieving target gene induction in lung cancer patients. Recently we have extended our gene induction studies, noting that the histone deacetylase inhibitor, Depsipeptide (FR901228/ NSC630176) significantly enhances target gene induction mediated by DAC under conditions that are potentially achievable in clinical settings. Depsipeptide alone exhibits only modest activity regarding gene induction, but mediates pronounced growth arrest and apoptosis in cultured lung cancer cells but not normal bronchial epithelium. In order to evaluate the ability of DP (Depsipeptide) to mediate apoptosis and target gene expression in vivo, lung cancer patients will receive four hour DP infusion on days 1 and 7 of a 21 day cycle; two cycles will be administered. The study will utilize a Simon two stage design for Phase II trials. Response to therapy will be recorded. In addition, NY-ESO-1, MAGE-3, p16, and P-glycoprotein expression will be evaluated in tumor specimens obtained before and after DP treatment to document extent of target gene induction; DP- mediated apoptosis and histone acetylation in these specimens will be examined using TdT techniques. In addition, immune response to NY-ESO-1 and MAGE-3 will be evaluated using in-vitro assays. Results of this study, together with those obtained from our phase I Decitabine trial will provide the clinical and molecular basis for a trial evaluating induction of tumor antigen and tumor suppressor gene expression in lung cancer patients by combination Decitabine/Depsipeptide treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically or cytologically proven primary small cell, and inoperable non-small cell lung cancers are eligible for evaluation. Patients with extrathoracic metastatic disease are eligible for study provided no intracranial or leptomeningeal metastases are evident. Patient must have measurable disease; those individuals who have received radiation therapy must have a measurable lesion outside the radiation portals or have evidence of biopsy proven "active" disease in the radiation field. Patients must have received or refused platinum-based therapy, and exhibit either refractory or progressive disease. Patients must have had no chemotherapy, biologic therapy, or radiation therapy for their malignancy within 30 days prior to depsipeptide treatment, and should have recovered from toxicities of prior therapy. Patients must have an ECOG performance status of 0-2. Patients must have adequate pulmonary reserve evidenced by FEV1 and DLCO greater than the 30% predicted, and pCO(2) less than 50 mm Hg and pO(2) greater than 60 mm Hg on room air ABG. Patients must be 18 years of age of age or older. Patients must have a platelet count equal to or exceeding 100,000, an ANC equal to or greater than 1500, a normal PT and adequate hepatic and renal function as evidenced by a total bilirubin of less than 1.5 mg/dl, and creatinine less than 1.5 mg/dl. Patients with serum creatinine greater than or equal to 1.5 mg/dl may be eligible for study if the creatinine clearance equals or exceeds 60 ml/min. Patients with a history of coronary artery disease, previous transmural myocardial infarction, congestive heart failure, or cardiac dysrhythmia will have cardiology consultation. Subsequent evaluation will consist of stress/redistribution thallium, MUGA scan, or coronary angiography as indicated. Patients with fixed defects on thallium scanning and adequate (greater than 40%) ejection fraction will be eligible following cardiology clearance. Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent, and undergo tumor biopsies to evaluate NY-ESO-1, MAGE-3, p16, and P-glycoprotein expression as well as histone acetylation prior to, and after, depsipeptide treatment. Participants must agree to practice approved methods of birth control while on study and for six months following completion of chemotherapy. EXCLUSION CRITERIA: Patients with primary and metastatic lung cancer which cannot be readily biopsied by bronchoscopic or percutaneous fine needle aspiration techniques will be excluded. Patients who have received three or more prior chemotherapy regimens will not be eligible for study. Newly diagnosed patients with limited stage SCLC and operable NSCLC will be excluded. Patients with active intracranial and leptomeningeal metastases will be excluded. Patients who have received resection or radiation therapy for intracranial metastatic disease may be eligible provided there is no evidence of active disease on two MRI scans one month apart and they require no anticonvulsant medications or steroids to control residual symptoms. Patients with life expectancy less than three months will be excluded. Patients with prior depsipeptide exposure, prior doxorubicin with total dose greater than 450 mg/m2, or nitrosourea/mitomycin-C within 4 weeks prior to depsipeptide treatment, or radiation therapy to the lung or mediastinum within 4 weeks of planned treatment with depsipeptide. Patients with unstable angina, congestive heart failure, uncontrolled cardiac dysrhythmia, pulmonary embolism within six months, or deep venous thrombosis requiring anticoagulation will be excluded. Pregnant patients and lactating mothers will be excluded. Patients with active infections will be excluded. Patients with HIV will be excluded.
Total Enrollment: 19
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000123; 00-C-0123
Study Start Date: April 27, 2000
Record last reviewed: September 16, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005656
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3. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
4. Depsipeptide to Treat Lung Cancer
5. An Open Label Study of a Peptide Vaccine in Patients with Stage IIb or IIIa Non-Small Cell Lung Cancer
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Depsipeptide to Treat Lung Cancer
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