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Basic Trial Information
Summary Primary Objectives: 1. To determine the feasibility and toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. 2. To determine the effectiveness of L9-NC given by aerosol in combination with temozolomide in patients with solid tumors involving the lungs. Further Study Information L9-NC and temozolomide each work by blocking certain tumor cell functions, which can keep tumor cells from growing. Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam, including having your blood drawn (about 2 teaspoons), a urine test, and a breathing function test. The breathing function test requires you to blow into a machine that will measure how well your lungs work. You will have a chest x-ray and a computerized tomography (CT) scan of your chest to measure how much disease you have. You will also have a CT or a magnetic resonance imaging (MRI) scan of other sites of your body, other than your lungs, where you may have disease. Females who are able to have children must have a negative blood or urine pregnancy test. If you are found to be eligible to take part in this study, you will be given the L9-NC aerosol (an inhaled spray) by mouth through a face mask for Cycle 1 of therapy. You will receive L9-NC over about 30 minutes once a day, for 5 days in a row. This will be done for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment. A treatment cycle lasts for 4 weeks. Your first L9-NC aerosol treatment, during Cycle 1, will be given at M.D. Anderson. You may receive the rest of your treatments at home, if you experienced no bad side effects with the first aerosol treatment. During Cycle 2 of therapy, if you have not experienced any intolerable side effects, you will be given temozolomide. You will receive temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will also continue to receive the L9-NC aerosol over about 30 minutes once a day, for 5 days in a row, for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment. During Cycle 3 of therapy, if you have not experienced any intolerable side effects, you will continue to be given temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will receive the L9-NC aerosol twice a day, about 12 hours apart, over about 30 minutes, for 5 days in a row, for 2 weeks. If you experience any bad side effects during Cycle 2, your dose of temozolomide will be decreased, and you will continue to receive L9-NC aerosol once a day (instead of twice a day), for 5 days in a row, for 2 weeks. For all further cycles of treatment, if you experienced any bad side effects during Cycle 3, you will receive L9-NC only once a day, instead of twice a day. If you are already receiving L9-NC only once a day, and you experience intolerable side effects in Cycle 3, you will be taken off this study. You will be shown how to do spirometry (a lung test that measures how much and how fast air moves out of the lungs) to monitor the safety of your therapy. You will be asked to do this after each treatment cycle, for the first 2 cycles. If your dose of L9-NC is increased to twice a day, you will also be asked to do spirometry after the second dose of the day during Cycle 3. For future cycles, you will be asked to do spirometry after the last dose of L9-NC, on the first day of each week of treatment. The results of spirometry will need to be sent to M.D. Anderson by telephone, after each test. The results will be sent electronically. They will be reviewed every day after they are received, and you will be contacted if there are abnormal results. Your doctor may also perform additional spirometry as needed. You will be examined by a doctor before the second and third cycle of therapy (every 4 weeks). You will have blood drawn (about 2 tablespoons) every week during the first 2 to 3 cycles of therapy. After Cycle 3 of therapy, blood tests (about 2 tablespoons) will be done before each cycle of therapy. Chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to measure your disease and will be repeated after every 3 cycles of therapy. You will also have a breathing function test, if the doctor thinks it is necessary. If your tumor size decreases during this treatment, you may have other therapy performed, such as surgery, radiation, or radiofrequency ablation, outside of this study. If the treatment in this study alone, or in combination with other therapy, results in complete disappearance of your disease, your treatment on this study may continue for up to 6 more cycles. You will be taken off this study if your disease gets worse or you experience any intolerable side effects. If you are taken off this study for intolerable side effects, you will be followed-up for 30 days after treatment ends or until your side effects go away. If you have a complete remission, chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to look for disease about every 3 months after completion of treatment. This is an investigational study. L9-NC is authorized by the FDA for use in research only. Temozolomide is approved by the FDA. The use of these drugs together in this study is experimental. Up to 40 patients will take part in this study. All will be enrolled at M.D. Anderson. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors M. D. Anderson Cancer Center at University of Texas
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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