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← Malignant Peritoneal Neoplasm

NCT02151448 · STUDY IN CONTEXT

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Only includes patients participating in the Phase 1 portion.

→

primary · POSTED

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).

Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

The length of time from the start of treatment that diagnosed patients are still alive.

Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery.

→

secondary · POSTED

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).

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.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Interleukin 10 (IL-10) Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT02151448
qol key
qol-0007
source section id
NCT02151448-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Interleukin 10 (IL-10) Levels
measure definition
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.
time frame
Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT02151448
qol key
qol-0010
source section id
NCT02151448-om-0010
source outcome index
10
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels
measure definition
Levels of stromal derived factor 1 alpha (SDF-1A/CXCL-12) chemokine in peripheral blood. Higher levels of SDF-1A/CXCL-12 is associated with good prognosis.
time frame
Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Tumor Necrosis Factor (TFNα) Cytokine Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT02151448
qol key
qol-0011
source section id
NCT02151448-om-0011
source outcome index
11
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Tumor Necrosis Factor (TFNα) Cytokine Levels
measure definition
Tumor necrosis factor (TFNα) cytokine concentration levels measures in peripheral blood. Higher TFNα levels is associated with good prognosis.
time frame
Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT02151448
trial label
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0000
    source section id
    NCT02151448-om-0000
    source outcome index
    0
    endpoint
    Recommended Phase 2 Dose (RP2D) (Phase 1)
    endpoint definition
    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.
    time origin
    Up to 24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only includes patients participating in the Phase 1 portion.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0001
    source section id
    NCT02151448-om-0001
    source outcome index
    1
    endpoint
    Adverse Events Possibly, Probably or Definitely Related to Study Treatment
    endpoint definition
    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).
    time origin
    Up to 24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0002
    source section id
    NCT02151448-om-0002
    source outcome index
    2
    endpoint
    Time to Progression (TTP)
    endpoint definition
    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).
    time origin
    Up to18 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0003
    source section id
    NCT02151448-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    The length of time from the start of treatment that diagnosed patients are still alive.
    time origin
    Up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0004
    source section id
    NCT02151448-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    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).
    time origin
    Up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0005
    source section id
    NCT02151448-om-0005
    source outcome index
    5
    endpoint
    CXCL10 (Interferon Gamma-induced Protein 10) Levels
    endpoint definition
    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.
    time origin
    Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
    regimen
    α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0001
    arm key
    OG000
    arm label
    α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
    regimen
    α DC1 Vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0002
    arm key
    OG000
    arm label
    α DC1 Vaccine + Chemokine Modulatory Regimen
    regimen
    α DC1 Vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    55
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0003
    arm key
    OG000
    arm label
    α DC1 Vaccine + Chemokine Modulatory Regimen
    regimen
    α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0004
    arm key
    OG000
    arm label
    α DC1 Vaccine + Chemokine Modulatory Regimen
    regimen
    α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    outcome key
    om-0005
    arm key
    OG000
    arm label
    α DC1 Vaccine + Chemokine Modulatory Regimen
    regimen
    α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02151448-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    harm key
    EG000
    source section id
    NCT02151448-ae
    event group key
    EG000
    event group label
    Vaccine + Chemokine Modulatory Regimen
    serious affected
    17
    serious at risk
    64
    other affected
    46
    other at risk
    64
    frequency threshold
    5
    collection period
    3 years, 6 months
    event definition
    Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    qol key
    qol-0007
    source section id
    NCT02151448-om-0007
    source outcome index
    7
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Interleukin 10 (IL-10) Levels
    measure definition
    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.
    time frame
    Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    qol key
    qol-0010
    source section id
    NCT02151448-om-0010
    source outcome index
    10
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels
    measure definition
    Levels of stromal derived factor 1 alpha (SDF-1A/CXCL-12) chemokine in peripheral blood. Higher levels of SDF-1A/CXCL-12 is associated with good prognosis.
    time frame
    Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm
    nct id
    NCT02151448
    qol key
    qol-0011
    source section id
    NCT02151448-om-0011
    source outcome index
    11
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Tumor Necrosis Factor (TFNα) Cytokine Levels
    measure definition
    Tumor necrosis factor (TFNα) cytokine concentration levels measures in peripheral blood. Higher TFNα levels is associated with good prognosis.
    time frame
    Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice