Clinical trial · Interventional
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer
NCT00776295CI-TRIAL-00009104terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- adeno virus vectored p53
- description
- Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
- interventionNames
- Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Primary outcomes (1)
- measure
- Number of Subjects Meeting 1-year Overall Survival
- timeFrame
- up to one year
- description
- Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
Secondary outcomes (1)
- measure
- 3 Year Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis. * Measurable disease at the time of initial therapy * Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy. * Responsive disease to standard chemoradiation therapy as defined by RECIST * Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation * CBC with an absolute neutrophil count (ANC) \>/= 1,000/uL, hemoglobin \>/= 8.0 g/DL and platelet count \>/= 75,000/uL. * Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial. * Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal. * Creatinine clearance of \>/= 60 mL/min * Pulmonary: DLCO greater than 50% * Cardiac: left ventricular ejection fraction greater than 45% Exclusion Criteria: * Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation * Pregnant or lactating woman * HIV infection confirmed by NAT * Common variable immunodeficiency * Active CNS malignancy * Active bacterial, fungal or viral infection * Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care * Prior history of autologous or allogeneic hematopoietic cell transplantation * Presence of protocol specific comorbid conditions
References
Publications (0)
Data not yet available
No reference posted for this study.