Clinical trial · Interventional
Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
Combination Immunotherapy for Lung Cancer
NCT00601796CI-TRIAL-00010409completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All-trans retinoic acid (ATRA) | Drug | Tretinoin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Vaccine Treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Immunotherapy
- description
- Vaccine + Cytoxan + ATRA as outlined in Detailed Description
- interventionNames
- Biological: Vaccine Treatment
- Drug: Cyclophosphamide
- Drug: All-trans retinoic acid (ATRA)
Primary outcomes (1)
- measure
- Number of Evaluable Participants With Tumor Response
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 human leukocyte antigen A0201 (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
References
Publications (0)
Data not yet available
No reference posted for this study.