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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2005042 | Other Identifier | UM/Sylvester Comprehensive Cancer Center | |
| WIRB-20051678 | Other Identifier | Western IRB (WIRB) |
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Per request of Principal Investigator this study was closed.
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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.
OUTLINE: This is a multicenter study.
Phase I (single site [University of Miami Sylvester Comprehensive Cancer Center]): Patients receive allogeneic B7.1 and human leukocyte antigen-A1 (HLA-A1) transfected tumor cell vaccine intradermally (ID) in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses. If no more than 1 of 6 patients experience a probable or definitively treatment related adverse effect (i.e., grade 2 autoimmune or grade 3-4 of any type), patients proceed to the phase II portion of the study. If 2 or more (out of 6) patients experience treatment related adverse effects the study stops.
Phase II (randomized): Patients are stratified according to study site (University of Miami Sylvester Comprehensive Cancer Center or Memorial Regional Hospital), type of prior first-line treatment (platinum and taxane vs platinum and gemcitabine), and presence of brain metastasis (yes vs no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then once a year thereafter.
PROJECTED ACCRUAL: A total of 66 patients (6 patients for phase I and 60 patients for phase II) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Allogeneic B7.1/HLA-A1 | Experimental | Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally. |
|
| Arm II: Placebo | Placebo Comparator | Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic B7.1/HLA-A1 | Biological | Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression-free Survival (Phase 2) | Date of randomization to the earliest date of documented progression. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2) |
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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:
Age ≥ 18 years.
Signed informed consent.
Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Luis E. Raez, MD, FACP | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States | ||
| University of Miami Sylvester Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14605671 | Background | 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. doi: 10.1038/sj.cgt.7700641. | |
| 15461522 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Up to 13 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 Edema limbs | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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Study closed early due to low enrollment. A minimum of 2 patients were required for Phase 1, however, this requirement was not met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Raez MD | UM/Sylvester Comprehensive Cancer Center | 305-243-4909 | lraez@med.miami.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018122 | B7-1 Antigen |
| ID | Term |
|---|---|
| D060887 | B7 Antigens |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Other | Given intradermally |
|
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 |
| 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 |
| 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 |
| 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 |
| 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-γ), 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 |
| Miami |
| Florida |
| 33136 |
| 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. doi: 10.1021/la049646l. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Progression-free Survival (Phase 2) | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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. | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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). | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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. | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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. | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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. | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | 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-γ), 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). | This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available. | Posted | Baseline, Week 7 and Week 13 |
|
|
| 1 |
| 1 |
| 0 |
| 1 |
| Grade 3 Vascular access complication | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |