Lung Cancer Clinical Trial
Official title:
Phase I/II Clinical Trial of Immunotherapy With an Allogeneic B7.1/HLA-A1 Transfected Tumor Cell Vaccine in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer That Have Completed First Line Chemotherapy
Verified date | September 2017 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune
response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and
to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung
cancer who have finished first-line chemotherapy.
Status | Terminated |
Enrollment | 1 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
INCLUSION CRITERIA - Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease. - Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2. - Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min. - Pulmonary Function Requirements: - All patients will undergo evaluation of pulmonary function prior to enrollment. - Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) < 45mm. - Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol. - Age = 18 years. - Signed informed consent. - Patients should have absolute neutrophil count (ANC) = 1000/mm3; platelets (PLT) = 80,000/mm3. EXCLUSION CRITERIA: - Small cell carcinoma of the lung. - Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study. - Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer. - Concomitant steroid or other immunosuppressive therapy. - Active infection, or less than 7 days since therapy for acute infections. - Pericardial effusion. - Currently receiving chemotherapy for another condition (such as arthritis). - Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC. - Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. - Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential). - Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study. - Known HIV infection - Untreated or uncontrolled brain metastasis. - Liver Enzymes greater than 3 times the institutional upper limit. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Regional Hospital | Hollywood | Florida |
United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
Frankowski DJ, Raez J, Manners I, Winnik MA, Khan SA, Spontak RJ. Formation of dispersed nanostructures from poly(ferrocenyldimethylsilane-b-dimethylsiloxane) nanotubes upon exposure to supercritical carbon dioxide. Langmuir. 2004 Oct 12;20(21):9304-14. — View Citation
Raez LE, Cassileth PA, Schlesselman JJ, Padmanabhan S, Fisher EZ, Baldie PA, Sridhar K, Podack ER. Induction of CD8 T-cell-Ifn-gamma response and positive clinical outcome after immunization with gene-modified allogeneic tumor cells in advanced non-small-cell lung carcinoma. Cancer Gene Ther. 2003 Nov;10(11):850-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preliminary Safety Profile (Phase 1) | This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination. | Up to 13 weeks | |
Primary | Progression-free Survival (Phase 2) | Date of randomization to the earliest date of documented progression. | ||
Secondary | Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2) | Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses. | About 13 weeks | |
Secondary | Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2) | Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact). | From Week 1 of Study Therapy until Death or Withdrawal of Consent | |
Secondary | Safety Profile (Phase 2) | The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination. | About 13 weeks | |
Secondary | Response to Second-line Chemotherapy After Disease Progression (Phase 2) | The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls. | From Week 1 of Study Therapy until Death or Withdrawal of Consent | |
Secondary | Overall Survival (Phase 2) | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive. | Date of randomization to the recorded date of death | |
Secondary | Correlative Immunological Studies in Study Participants (Phase 2) | The time course of patients' adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-?), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13). | Baseline, Week 7 and Week 13 |
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