Clinical trial · Interventional
Autologous Tumor DRibble Vaccine in Patients With Non-Small Cell Lung Cancer
A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
NCT00850785CI-TRIAL-00024054DRibblecompletedPhase 1ClinicalTrials.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)
This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease. The primary objective of this trial is to evaluate immune responses induced by autologous DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer 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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DRibble vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles.
- timeFrame
- DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
Secondary outcomes (1)
- measure
- Tumor response (RECIST criteria)
- timeFrame
- Week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB or IV NSCLC. * Adequate pleural effusion (\>600 cc) or subcutaneous metastases (\>1 cc) for * DRibble vaccine production. * Measurable or evaluable disease. * No or one prior chemotherapy regimen for advanced NSCLC. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Age \> 18 years. * CD4 count \> 200 per cc. * Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the toxicities that docetaxel may have on the forming fetus, spermatogenesis or the nursing child. * Also, because pregnancy may alter immune function it may limit the treatment efficacy. * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. Anticipated lifespan minimum 6 months. Exclusion Criteria: * Prior vaccine or gene therapy for cancer. * Untreated brain metastases or spinal cord compression. * Active autoimmune disease. * Active other malignancy. * Known hypersensitivity to docetaxel. * HIV positive and/or Hepatitis B or C positive. * Patients receiving any other concurrent investigational treatment. * Other medical or psychiatric conditions that in the opinion of the Principal * Investigator would preclude safe participation in protocol.
References
Publications (1)
- DERIVEDSanborn RE, Ross HJ, Aung S, Acheson A, Moudgil T, Puri S, Hilton T, Fisher B, Coffey T, Paustian C, Neuberger M, Walker E, Hu HM, Urba WJ, Fox BA. A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer. J Immunother Cancer. 2017 Dec 19;5(1):103. doi: 10.1186/s40425-017-0306-6. PMID 29258618