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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 December 2012 |
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Main ID: |
NCT00601796 |
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Date of registration:
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19/01/2008 |
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Primary sponsor: |
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Public title:
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Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
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Scientific title:
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Combination Immunotherapy for Lung Cancer |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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24 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00601796 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alberto Chiappori, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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H. Lee Moffitt Cancer Center and Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed metastatic adenocarcinoma of the lung
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- No radiation therapy within 2 weeks of first vaccine administration
- No chemotherapy within 4 weeks of first vaccine administration
- No steroid therapy within 4 weeks of first vaccine administration
- Patient's written informed consent
- Adequate organ function (measured within a week of beginning treatment)
- Patients will be tested for HLA-A0201 as determined by flow cytometry followed by
molecular analysis of a peripheral blood specimen, however this result will not be an
inclusion criterion.
- Measurable metastatic tumor as defined by standard Response Evaluation Criteria In
Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one
dimension with the longest diameter greater than or equal 20mm. With spiral computer
tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one
dimension.
- Patient's must have received, and completed first line chemotherapy.
Exclusion Criteria:
- Symptomatic brain metastasis
- Any acute medical problems requiring active intervention
- Current corticosteroid (other than replacement doses in patients who are hypoadrenal)
or other immunosuppressive therapy
- Any other pre-existing immunodeficiency condition (including known HIV infection)
- Pregnant or lactating women -- Patients in reproductive age must agree to use
contraceptive methods for the duration of the study (*A pregnancy test will be
obtained before treatment).
- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Biological: Vaccine Treatment
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Drug: ATRA
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Drug: Cyclophosphamide
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Primary Outcome(s)
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Number of Participants With Tumor Response
[Time Frame: 2 years]
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Secondary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: 2 years]
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Number of Participants With Overall Survival (OS)
[Time Frame: 2 years]
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Time to Progression (TTP)
[Time Frame: 2 years]
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Secondary ID(s)
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MCC-14744
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NIH-OBA-0608-801
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P30CA076292
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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