Expired Study
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Tampa, Florida 33612


Purpose:

The purpose of this study is to find out if using high dose chemotherapy and hematopoietic cell transplant (HCT) in combination with lung cancer vaccines will improve survival in people with small cell lung cancer. Hematopoietic cells are blood cells that are responsible for making other blood cells (like red and white blood cells and platelets). When high doses of chemotherapy are given, the number of blood cells go way down and, by giving hematopoietic cells (a transplant), the numbers of blood cells come back up. This lessens the risk of having an infection or serious bleeding after high dose chemotherapy. High dose chemotherapy and HCT has been successful in some people with small cell lung cancer. In many cases, though, the cancer comes back over time. For this reason, other kinds of therapy are being tested in combination with high dose chemotherapy and HCT. In this research study, the study doctors will be testing a vaccine directed against lung cancer to see if it will keep the lung cancer from coming back after HCT.


Study summary:

Treatment Plan: - Hematopoietic cell mobilization and collection. - Pre-transplant vaccination. - Collection of T-cells. - T-cell Infusion. - Peripheral blood hematopoietic cell transplant. - Follow-up after transplant as follows. Patients will need to come to the outpatient BMT Treatment Center routinely for several weeks. They may need to be seen frequently, depending on how they are doing. These visits will become less frequent as they return toward their baseline health. About 30 days after transplant, they will have the following tests done: - Complete history and physical exam - Blood tests for the following: - Complete blood count - Blood clotting test - Serum chemistries - Tests of liver and kidney function - Urine tests to check the patient's kidney function; one of these tests will involve collecting their urine over 24 hours - Electrocardiogram (ECG) to check the electrical activity of their heart - MUGA scan to see how well their heart pumps blood - Lung function testing - CT scans and a bone scan to assess the effect of the transplant on the lung cancer About 2 months after the T-cell infusion, patients will have another small shot under the skin to determine their immune system's ability to react to certain allergens. About 2 months after their transplant, patients will go back to being seen by their lung cancer doctor at Moffitt. They will continue to have visits in the BMT Clinic every 6 months. At 6 months, 1 year, 2 years, 3 years and 5 years after transplant, patients will have CT scans and a bone scan to assess the effect of the transplant on the lung cancer. They may have these test more frequently if they are having signs or symptoms of the lung cancer getting worse.


Criteria:

Inclusion Criteria: - Patients with histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis. LS is defined as tumor confined to the hemithorax of origin, the mediastinum, and the supraclavicular nodes, which can be encompassed within a tolerable radiation therapy port. - Measurable disease at the time of initial therapy. Also, patients will have re-staging of disease after completion of standard chemoradiotherapy (i.e. 4 cycles of etoposide and cisplatinum (or alternative regimens) and concurrent chemoradiotherapy +/- PCI). Patients could be in complete remission (CR) or partial remission (PR) - Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy. Patients who have received acceptable standard radiotherapy regimens, other than that described in section 4.1, are eligible for the trial provided that total dose of chest radiation is ≤ 5,000 cGy. - Responsive disease to standard chemoradiation therapy as defined by RECIST - Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation; however, those patients who choose not receive prophylactic cranial irradiation will still be eligible and will not be excluded. - CBC with an absolute neutrophil count (ANC) ≥ 1,000/uL, hemoglobin ≥ 8.0 g/DL and platelet count ≥ 75,000/uL. - Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial. - Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal. - Creatinine clearance of ≥ 60 mL/min - Pulmonary: DLCO greater than 50% - Cardiac: left ventricular ejection fraction greater than 45% - Signed informed consent form in accordance with institutional and federal law policies. Exclusion Criteria: - Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation - Pregnant or lactating woman - HIV infection confirmed by NAT - Common variable immunodeficiency - Active CNS malignancy - Active bacterial, fungal or viral infection - Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care - Prior history of autologous or allogeneic hematopoietic cell transplantation - Presence of any of the following comorbid conditions: - History of recent myocardial infarction (within 6 months) - Symptomatic congestive heart failure - Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency) - Untreated thoracic or abdominal aneurysm (6 cm or more) - History of recent cerebrovascular accident including transient ischemic attacks with residual hemiplegia/paraplegia - Dementia - Connective tissue/rheumatologic disorders and autoimmune disorders - History of prior solid tumor excluding skin or cervical carcinoma after curative resection


NCT ID:

NCT00609583


Primary Contact:

Principal Investigator
Mohamed A. Kharfan-Dabaja, M.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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