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Sponsored by: |
H. Lee Moffitt Cancer Center and Research Institute |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00609583 |
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.
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Biological: PBHCT followed by Dendritic Vaccination and T Cell transfer |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer |
Estimated Enrollment: | 53 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
The primary objective of this phase II trial is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
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Biological: PBHCT followed by Dendritic Vaccination and T Cell transfer
High Dose Chemotherapy:
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Treatment Plan:
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:
Blood tests for the following:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Presence of any of the following comorbid conditions:
Contact: Mohamed A. Kharfan-Dabaja, M.D. | 813-745-3988 | mahamed.kharfan-dabaja@moffitt.org |
Contact: Jennifer Barolo, R.N. | 813-745-2721 | jennifer.barolo@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Mohamed A. Kharfan-Dabaja, M.D. 813-745-3988 mohamed.kharfan-dabvaja@moffitt.org | |
Contact: Jennifer Barolo, R.N. 813-745-2721 | |
Principal Investigator: Mohamed A. Kharfan-Dabaja, M.D. | |
Sub-Investigator: Claudio Anasetti, M.D. | |
Sub-Investigator: Scott Antonia, M.D., PhD. | |
Sub-Investigator: Ernesto Ayala, M.D. | |
Sub-Investigator: Gerold Bepler, M.D. | |
Sub-Investigator: Alberto Chiappori, M.D. | |
Sub-Investigator: Hugo Fernandez, M.D. | |
Sub-Investigator: Dmitry Gabrilovich, M.D., PhD. | |
Sub-Investigator: William Janssen, PhD. | |
Sub-Investigator: Lia Perez, M.D. | |
Sub-Investigator: George Simon, M.D. | |
Sub-Investigator: Craig Stevens, M.D. |
Principal Investigator: | Mohamed A. Kharfan-Dabaja, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Mohamed A. Kharfan-Dabaja, M.D. ) |
Study ID Numbers: | MCC-14955, USFIRB#105632 |
Study First Received: | January 24, 2008 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00609583 |
Health Authority: | United States: Institutional Review Board |
SCLC LS-SCLC Limited Stage Small Cell Lung Cancer |
hematopoietic cell transplant HCT vaccine |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carboplatin Cyclophosphamide Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Ifosfamide |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Mesna Etoposide Isophosphamide mustard Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |