Trial · NCT02151448
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
NCT02151448, Phase 1, Phase 2, Completed, David Bartlett; results first posted 2020-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies. Trials, record NCT02151448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02151448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
- NCT number
- NCT02151448
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- David Bartlett
- Conditions
- Malignant Neoplasm of Pancreas Metastatic to Peritoneal Surface, Malignant Peritoneal Mesothelioma, Peritoneal Carcinomatosis
- Interventions
- DC vaccine, Celecoxib, Interferon Alfa-2b, rintatolimod
- First posted
- 2014-05-30
- Last updated
- 2020-07-20
- Results first posted
- 2020-01-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) (Phase 1) | Up to 24 weeks | Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study. |
| Primary | Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Up to 24 weeks | Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events). |
| Secondary | Time to Progression (TTP) | Up to18 months | The length of time from the start of treatment until disease progression, per RECIST 1.1 considering only patients whose deaths were from cancer. Disease progression per RECIST 1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Overall Survival (OS) | Up to 5 years | The length of time from the start of treatment that diagnosed patients are still alive. |
| Secondary | Progression-free Survival (PFS) | Up to 5 years | The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | CXCL10 (Interferon Gamma-induced Protein 10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Chemokine CXCL10 (Interferon gamma-induced protein 10) concentration levels measures in peripheral blood as a biomarker of anti-tumor activity. Increased levels can be predictive of good prognosis. |
| Secondary | CXCL11 (C-X-C Motif Chemokine 11) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | CXCL11 (C-X-C motif chemokine 11) protein concentration levels measures in peripheral blood. Increased levels can be predictive of good prognosis. |
| Secondary | Interleukin 10 (IL-10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin 10 (IL-10) (human cytokine synthesis inhibitory factor (CSIF)) concentration levels measures in peripheral blood. Increased levels of IL-10 is associated with advanced disease and poor prognosis. |
| Secondary | Interleukin 6 (IL-6) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin 6 (IL-6) concentration levels measures in peripheral blood. Increased levels of IL-6 is associated with associated with advanced disease and poor prognosis. |
| Secondary | Interleukin-8 (IL-8) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin-8 (IL-8) cytokine concentration levels measures in peripheral blood. Increased levels of IL-8 is associated with associated with advanced disease and poor prognosis. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose (RP2D) (Phase 1) | Up to 24 weeks | Only includes patients participating in the Phase 1 portion. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Up to 24 weeks | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression (TTP) | Up to18 months | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery and response to treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 5 years | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 5 years | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment. | months | MEDIAN |
| SECONDARY | CXCL10 (Interferon Gamma-induced Protein 10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay. | pg/mL | MEAN |
| SECONDARY | CXCL11 (C-X-C Motif Chemokine 11) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay. | pg/mL | MEAN |
| SECONDARY | Interleukin 10 (IL-10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay. | pg/ml | MEAN |
| SECONDARY | Interleukin 6 (IL-6) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay. | pg/mL | MEAN |
| SECONDARY | Interleukin-8 (IL-8) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay. | pg/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase 2 Dose (RP2D) (Phase 1) | Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen | 5 MU/M^2IFN alpha | 5 | Participants | |
| Recommended Phase 2 Dose (RP2D) (Phase 1) | Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen | 10 MU/M^2 IFN alpha | 0 | Participants | |
| Recommended Phase 2 Dose (RP2D) (Phase 1) | Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen | 20 MU/M^2IFN alpha (RP2D) | 4 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Anemia : Grade 1-2 | 3 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Anemia : Grade 3-4 | 1 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Blurred vision : Grade 1-2 | 1 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Blurred vision : Grade 3-4 | 0 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Bruising : Grade 1-2 | 1 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Bruising : Grade 3-4 | 0 | Participants | |
| Adverse Events Possibly, Probably or Definitely Related to Study Treatment | α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen | Chills : Grade 1-2 | 34 | Participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | α DC1 Vaccine + Chemokine Modulatory Regimen | 9 | |
| Phase 1 | COMPLETED | α DC1 Vaccine + Chemokine Modulatory Regimen | 9 | |
| Phase 1 | NOT COMPLETED | α DC1 Vaccine + Chemokine Modulatory Regimen | 0 | |
| Phase 2 | STARTED | α DC1 Vaccine + Chemokine Modulatory Regimen | 55 | |
| Phase 2 | COMPLETED | α DC1 Vaccine + Chemokine Modulatory Regimen | 55 | |
| Phase 2 | NOT COMPLETED | α DC1 Vaccine + Chemokine Modulatory Regimen | 0 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sinus bradycardia | Cardiac disorders | Vaccine + Chemokine Modulatory Regimen | 4 | 64 | |
| other | Constipation | Gastrointestinal disorders | Vaccine + Chemokine Modulatory Regimen | 4 | 64 | |
| other | Weight gain | Investigations | Vaccine + Chemokine Modulatory Regimen | 4 | 64 | |
| other | Hypokalemia | Metabolism and nutrition disorders | Vaccine + Chemokine Modulatory Regimen | 4 | 64 | |
| other | Flu like symptoms | General disorders | Vaccine + Chemokine Modulatory Regimen | 5 | 64 | |
| other | Blood bilirubin increased | Investigations | Vaccine + Chemokine Modulatory Regimen | 5 | 64 | |
| other | Creatinine increased | Investigations | Vaccine + Chemokine Modulatory Regimen | 5 | 64 | |
| other | Abdominal pain | Gastrointestinal disorders | Vaccine + Chemokine Modulatory Regimen | 6 | 64 | |
| other | Alanine aminotransferase increased | Investigations | Vaccine + Chemokine Modulatory Regimen | 6 | 64 | |
| other | Lipase increased | Investigations | Vaccine + Chemokine Modulatory Regimen | 7 | 64 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine + Chemokine Modulatory Regimen | 23 | 64 |
| Total, other adverse events | Vaccine + Chemokine Modulatory Regimen | 46 | 64 |
| Total, serious adverse events | Vaccine + Chemokine Modulatory Regimen | 17 | 64 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA132714 | Directing Tumor-specific T cells to Tumors | KALINSKI, PAWEL | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02151448
GET https://conductscience.org/api/trials/v1/NCT02151448/results?page=2