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Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer Clinical research trials and Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer  Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
For Condition: Sarcoma,Breast Cancer,Melanoma,Lung Cancer,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will explore the safety and effectiveness of an inhaled form of the drug doxorubicin (Adriamycin) for treating lung cancer. Doxorubicin has been given intravenously (through a vein) for many years to treat various types of cancer. Animal studies indicate that an inhaled form of the drug delivered directly to the lungs may be more effective against lung cancer than intravenous dosing. Therefore, this small, preliminary study will determine the safest dose of inhaled doxorubicin, examine its side effects, study how the body handles it and evaluate tumor response to it. Patients 18 years or older with cancer of the lung or trachea or other cancer that has spread to the lung may be eligible for this study. The cancer must not be amenable to cure with standard chemotherapy, radiation therapy or surgery. Study participants will receive one dose of doxorubicin every 3 weeks for a total of three doses in 9 weeks. The treatments are administered in the hospital. The patient inhales the drug through a mouthpiece on a special machine. Blood pressure, heart rate and breathing are measured for 30 minutes after the drug is delivered. The patient is monitored overnight in the hospital and has a chest X-ray and oxygen level check the following morning before being discharged. Patients undergo the following tests: 1. Blood tests - Seven teaspoons of blood are taken for screening purposes before treatment starts and again between treatments to evaluate the effects of the medicine. 2. Lung function tests -A breathing test to measure how much air the patient can move into and out of the lungs is done before treatment starts, between treatments, and 3 weeks after treatment ends. 3. Arterial blood gases - Blood is taken from an artery instead of a vein, in order to test blood gases. 4. Scans - A CT scan and chest X-ray are done before each treatment and 3 weeks after treatment ends. 5. Electrocardiogram - An EKG is done before treatment starts. 6. Technetium deposition and scintigraphy - This imaging test is done before treatment starts to calculate the drug dose. The patient inhales a small amount of a radioactive substance called technetium 99m DTPA, using the same machine that is used to deliver the doxorubicin. A gamma camera takes pictures of the chest to see the movement of the radioactive material in the lungs. There is a chance that patients may benefit from this experimental treatment, although this is not yet known. The findings of this study may help scientists develop more effective treatments for lung cancer patients in the future.
Details: Extensive preclinical experiments performed at Battelle Memorial Institute demonstrate a significant pharmacokinetic advantage for doxorubicin delivered via aerosolization techniques relative to intravenous administration in animals with either spontaneous or experimentally induced pulmonary malignancies. As a means to determine the potential efficacy of aerosolized doxorubicin and examine the applicability of this technology for regional lung therapy, patients with unresectable pulmonary malignancies will receive three aerosolized doxorubicin treatments utilizing a phase 1 study design and a modified Fibonacci dose escalation schema. Pulmonary and systemic toxicity, pharmacokinetics, and response to therapy will be recorded. These efforts may enable the evaluation of other pharmacologic agents or gene therapy constructs delivered via aerosolization techniques for the treatment and prevention of aerodigestive tract cancers.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Pathologic evidence of cancer confirmed by the NIH Clinical Center Pathology Department. Clinical evidence of primary lung or tracheal cancer, or cancer metastatic to the lung with a life expectancy greater than 3 months. Patients with extrathoracic metastases may be eligible for study provided these sites are stable and the pulmonary sites are the patient's primary life-threatening sites of disease and there is credible evidence that this procedure will potentially benefit the patient. Patients must not be potentially curable by standard chemotherapy, radiotherapy or surgical procedures. Age greater than or equal to 18 years. ECOG performance status of 0 or 1. Adequate bone marrow, hepatic, and renal function, as evidenced by the following: ANC greater than or equal to 1.5 K/UL, platelet count greater than or equal to 100,000/mm(3), and Hgb greater than or equal to 10g/dl; Total Bilirubin less than or equal to 1.0 mg/dl, AST and ALT less than 1.5 x upper limit of normal; Creatinine less than or equal to 1.6 mg/dl or creatinine clearance greater than or equal to 60 ml/min/1.7m(2) BSA Patients must have the following pulmonary function test values: DLCO greater than or equal to 50% predicted; FVC greater than or equal to 50% predicted; FEV(1) greater than or equal to 50% predicted; Resting oxygen saturation greater than or equal to 90%; Exercise oxygen saturation greater than or equal to 85%; Oxygen consumption greater than 50% predicted. Patients must not have received radiation therapy, biologic therapy or chemotherapy for four weeks prior to entry into this study, and they must have recovered from the toxic effects of prior therapy, excluding alopecia. Patients must not have received radiation therapy to the chest within 12 months prior to study entry. Patients who have received radiation therapy to the chest more than 12 months prior to study entry are eligible provided that no more than approximately 20% of the total lung volume was exposed and there is no evidence of radiation-induced pulmonary damage. Patients with only chest wall or primary breast irradiation are eligible. Patients who have undergone Radioactive Iodine (RAI) are also eligible. Left ventricular ejection fraction (LVEF) greater than or equal to 40% by MUGA scan or echocardiography. Patients with previous doxorubicin exposure will be eligible if MUGA scan or echocardiography confirms cardiac function. Measurable or evaluable disease is required. Patients must sign an informed consent indicating that they are aware of the neoplastic nature of his/her illness, the experimental nature of this study, alternative treatments, potential benefits, and risks. EXCLUSION CRITERIA: Patients with history of hypersensitivity to doxorubicin. Pregnant or lactating women are excluded, due to the unknown effects of doxorubicin on the developing fetus, and nursing infant. Men and women with reproductive potential must use an effective contraceptive method while on this study and for six months after completing chemotherapy. Patients with HIV are excluded due to the potential for opportunistic infection following doxorubicin-induced myelosuppression. Patients with germ cell tumor, leukemia, or lymphoma involving the lungs which is potentially treatable with systemic agents. Patients with prior therapy with mitomycin, bleomycin, nitrosoureas or herceptin. Patients with asthma Patients with complete atelectasis due to high grade airway obstruction. Patients who have undergone total pneumonectomy. Patients with unstable angina, congestive heart failure, or symptomatic arrhythmias. Patients who have congenital problems (e.g., cleft palate) or other anomalies which prevent tight fit of the mouthseal. Patients with prior history of radiation pneumonitis.
Total Enrollment: 33
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000088; 00-C-0088
Study Start Date: February 17, 2000
Record last reviewed: December 4, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004636
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Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
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