Clinical trial · Interventional
Radio-Immuno-Modulation in Lung Cancer
Radio-Immuno-Modulation for Advanced Lung Cancer: a Pilot Study Evaluating Tolerance and Immune Responses
NCT02579005CI-TRIAL-00074563RIMsuspendedPhase 1ClinicalTrials.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): Lack of ressources
Summary
Brief summary (as posted)
This project will assess the feasibility of treating advanced cancer using the immune system, without any anti-cancer drug. In this pilot study, the investigators propose combining low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells obtained from a donor. The patients will receive radiotherapy directed to one of the patient's tumors, as well as an immunomodulatory drug called cyclophosphamide. Thereafter, they will receive the infusion of donor immune cells.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients with a living donor | Biological | — | UNRESOLVED |
| Patients with a UCB donor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with a living donor
- description
- Radiation + PBMC
- interventionNames
- Biological: Patients with a living donor
- type
- EXPERIMENTAL
- label
- Patients with a UCB donor
- description
- Radiation + UCB
- interventionNames
- Biological: Patients with a UCB donor
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events
- timeFrame
- Up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Advanced lung cancer documented by a histo-pathological analysis; * Patients who received at least one line of anti neoplastic therapy; * Presence of at least one tumor mass \>1 cm and not previously irradiated; * Metastases situated in one of the following sites: lung, skeleton, lymph nodes or soft tissue; * Presence of at least one not previously irradiated metastasis; * Life expectancy greater than 3 months; * ECOG performance status ≤ 2. Exclusion criteria: * Second active cancer necessitating treatment; * History of autoimmune disease; * Patients dependent on immunosuppressive medications, including corticosteroids; * Decreased diffusion capacity below 40%, if radiation planned to a lung metastasis; * Patients needing urgent radiotherapy.
References
Publications (7)
- BACKGROUNDHodge JW, Guha C, Neefjes J, Gulley JL. Synergizing radiation therapy and immunotherapy for curing incurable cancers. Opportunities and challenges. Oncology (Williston Park). 2008 Aug;22(9):1064-70; discussion 1075, 1080-1, 1084. PMID 18777956
- BACKGROUNDBrody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9. PMID 20697067
- BACKGROUNDChi KH, Liu SJ, Li CP, Kuo HP, Wang YS, Chao Y, Hsieh SL. Combination of conformal radiotherapy and intratumoral injection of adoptive dendritic cell immunotherapy in refractory hepatoma. J Immunother. 2005 Mar-Apr;28(2):129-35. doi: 10.1097/01.cji.0000154248.74383.5e. PMID 15725956
- BACKGROUNDGulley JL, Arlen PM, Bastian A, Morin S, Marte J, Beetham P, Tsang KY, Yokokawa J, Hodge JW, Menard C, Camphausen K, Coleman CN, Sullivan F, Steinberg SM, Schlom J, Dahut W. Combining a recombinant cancer vaccine with standard definitive radiotherapy in patients with localized prostate cancer. Clin Cancer Res. 2005 May 1;11(9):3353-62. doi: 10.1158/1078-0432.CCR-04-2062. PMID 15867235
- BACKGROUNDDiaconescu R, Storb R. Allogeneic hematopoietic cell transplantation: from experimental biology to clinical care. J Cancer Res Clin Oncol. 2005 Jan;131(1):1-13. doi: 10.1007/s00432-004-0611-6. Epub 2004 Sep 28. PMID 15565456
- BACKGROUNDBaron F, Maris MB, Sandmaier BM, Storer BE, Sorror M, Diaconescu R, Woolfrey AE, Chauncey TR, Flowers ME, Mielcarek M, Maloney DG, Storb R. Graft-versus-tumor effects after allogeneic hematopoietic cell transplantation with nonmyeloablative conditioning. J Clin Oncol. 2005 Mar 20;23(9):1993-2003. doi: 10.1200/JCO.2005.08.136. PMID 15774790