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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Introgen Therapeutics |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00617409 |
The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the amount of time that people who have this disease will live. The vaccine will be made by inserting a gene (p53 gene) into a subset of the patient's own white blood cells. The vaccine will be given after the patient receives standard first-line chemotherapy, and may be given after second-line chemotherapy. One third of the people involved in the study will also be given a medication called All Trans Retinoic Acid (ATRA).
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Other: Observation Biological: Drug: Ad.p53-DC vaccines Drug: Ad.p53-DC vaccines + ATRA |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid |
Estimated Enrollment: | 81 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Observation until evidence of progressive disease (standard of care)
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Other: Observation
Group A - Observation, standard of care. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.
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B: Experimental
Ad.p53-DC vaccines
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Biological: Drug: Ad.p53-DC vaccines
Group B - Leukopheresis, vaccines x 3, rescan if stable repeat leukopheresis + three more vaccines. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.
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C: Experimental
Ad.p53-DC vaccines in combination with ATRA
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Drug: Ad.p53-DC vaccines + ATRA
Group C - Leukopheresis, ATRA pills with vaccine x 3, re-scan, stable-repeat leukopheresis plus ATRA pills with vaccine x 3-Rescan. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria at the time of initial registration:
Adequate organ function including:
Inclusion Criteria just prior to treatment with vaccines:
Adequate organ function:
Exclusion Criteria at the time of initial registration:
Exclusion Criteria for vaccine registration:
Contact: Alberto Chiappori, M.D. | 813-745-2158 | alberto.chiappori@moffitt.ofg |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Jamil Ahmed 813-745-7280 jamil.ahmed@moffitt.org | |
Principal Investigator: Alberto Chiappori, M.D. | |
Sub-Investigator: Soner Altiok, M.D., Ph.D. | |
Sub-Investigator: Gerold Bepler, M.D., Ph.D. | |
Sub-Investigator: Jhanelle Gray, M.D. | |
Sub-Investigator: Eric Haura, M.D. | |
Sub-Investigator: William Janssen, Ph.D. | |
Sub-Investigator: Tawee Tanvetyanon, M.D. | |
Sub-Investigator: Charles Williams, M.D. |
Principal Investigator: | Alberto Chiappori, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Alberto Chippori, M.D. ) |
Study ID Numbers: | MCC-15206, IND#9792, USFIRB#105790, IBC#0147NE, OBA 0705-857, INT 225-004 |
Study First Received: | February 5, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00617409 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SCLC |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Keratolytic Agents Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Paclitaxel Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Tretinoin Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Carcinoma Neuroendocrine Tumors Keratolytic Agents Carcinoma, Small Cell Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasms, Germ Cell and Embryonal Tretinoin Adenocarcinoma Dermatologic Agents Neoplasms, Glandular and Epithelial |