A Phase 2 interventional study of Vaccine Treatment and Cyclophosphamide in Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.
This protocol describes a phase II study involving patients with stage IV adenocarcinoma of the lung. Treatment will consist of Cyclophosphamide (300 mg/m²) to be given IV on day 1 and day 57. On day 4 immunization with intradermal vaccine injections at 4 separate sites (bilateral upper arms and bilateral upper thighs will be repeated every 14 days times 2 followed by every 28 days times 3 (day 4, 18, 32, 60, 88, and 116). Decavac (tetanus shot) 0.5 cc intramuscular (IM) will be given after the first vaccine. ATRA (150 mg/m2/day) oral three times daily (TID) dosing administered after the first and fourth vaccines (day 5-7 \& day 61-63). Those patients achieving stable disease (SD), partial response (PR), or complete response (CR) at restaging after the initial 6 vaccines will receive additional vaccines every 3 months until disease progression. The vaccine will consist of GM.CD40L bystander cells admixed with an equivalent number of the 2 allogeneic tumor cell lines. There will be a +/- 7 day window for all study related exams, tests, and procedures.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Biological: Vaccine Treatment · Drug: Cyclophosphamide · Drug: All-trans retinoic acid (ATRA)
We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
Also known as: Allogeneic Tumor Cell-Based Vaccines
Cyclophosphamide (300 mg/m\^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.
Also known as: cytoxan
All-trans retinoic acid was given (150/mg/m\^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Also known as: Vesanoid®, tretinoin, all trans retinoic acid, ATRA
Number of Evaluable Participants With Tumor Response
Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.
Time frame: 3 years
Median Time to Progression (TTP)
Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
Time frame: 3 years
Median Overall Survival (OS)
Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
Time frame: 3 years
Number of Participants With Serious Adverse Events (SAEs)
Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.
Time frame: 3 years
24 participants were accrued at a single center from 10/2006 to 6/2008.
| Milestone | Combination Immunotherapy |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.
| participants | Combination Immunotherapy |
|---|---|
| Number of Evaluable Participants With Tumor Response | 5 |
Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
| months | Combination Immunotherapy |
|---|---|
| Median Time to Progression (TTP) | 2.4 (0.3 to 4.6) |
Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
| months | Combination Immunotherapy |
|---|---|
| Median Overall Survival (OS) | 8 (3.5 to 12.5) |
Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.
| participants | Combination Immunotherapy |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 11 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination Immunotherapy | — | 11/24 (45.8%) | 24/24 (100%) |
| Event | Combination Immunotherapy |
|---|---|
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 3/24 |
| Pain - Tumor painGeneral disorders | 2/24 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/24 |
| HemoglobinBlood and lymphatic system disorders | 1/24 |
| Supraventricular and nodal arrhythmia - NOSCardiac disorders | 1/24 |
| HypotensionCardiac disorders | 1/24 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 1/24 |
| Death not associated with CTCAE term - Disease progression - NOSGeneral disorders | 1/24 |
| DehydrationGastrointestinal disorders | 1/24 |
| DiarrheaGastrointestinal disorders | 1/24 |
| Event | Combination Immunotherapy |
|---|---|
| Fatigue (asthenia, lethargy, malaise)General disorders | 19/24 |
| PainGeneral disorders | 19/24 |
| Pain - Head/headacheGeneral disorders | 14/24 |
| CoughRespiratory, thoracic and mediastinal disorders | 12/24 |
| NauseaGastrointestinal disorders | 10/24 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 10/24 |
| AnorexiaGastrointestinal disorders | 9/24 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 9/24 |
| HemoglobinBlood and lymphatic system disorders | 9/24 |
| Injection site reaction/extravasation changesSkin and subcutaneous tissue disorders | 8/24 |
24 participants were accrued at a single center from 10/2006 to 6/2008. There were 14 participants with evaluable peripheral blood mononuclear cells (PBMCs).
| Age, Categorical(Participants) | Combination Immunotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 12 |
| Age Continuous(years) | Combination Immunotherapy |
|---|---|
| Median | 64 (49 to 85) |
| Sex: Female, Male(Participants) | Combination Immunotherapy |
|---|---|
| Female | 12 |
| Male | 12 |
| Region of Enrollment(participants) | Combination Immunotherapy |
|---|---|
| United States | 24 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute