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← Gastrointestinal Stromal Tumors

NCT00623831 · STUDY IN CONTEXT

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen

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. 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

Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.

The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.

→

primary · POSTED

Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.

The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.

→

secondary · POSTED

Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]

The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.

→

secondary · POSTED

Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.

The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.

→

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 · Number of Participants With Serum NY-ESO-1-specific Immune Responses

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-gastrointestinal-stromal-tumors
nct id
NCT00623831
qol key
qol-0002
source section id
NCT00623831-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Number of Participants With Serum NY-ESO-1-specific Immune Responses
measure definition
Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]
time frame
Up to 3 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.
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-gastrointestinal-stromal-tumors
nct id
NCT00623831
trial label
A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen
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.
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
4
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0000
    source section id
    NCT00623831-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Treatment-emergent Adverse Events (TEAEs)
    endpoint definition
    Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.
    time origin
    Up to 3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0001
    source section id
    NCT00623831-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU
    endpoint definition
    Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.
    time origin
    Weeks 1 through 6
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0002
    source section id
    NCT00623831-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Serum NY-ESO-1-specific Immune Responses
    endpoint definition
    Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]
    time origin
    Up to 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0003
    source section id
    NCT00623831-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Best Overall Tumor Response
    endpoint definition
    Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
    time origin
    Up to 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1 (Safety Analysis Set)
    regimen
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2 (Safety Analysis Set)
    regimen
    Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1 (Safety Analysis Set)
    regimen
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort 1 (Immune Response Analysis Set)
    regimen
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cohort 1 (Tumor Response Analysis Set)
    regimen
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cohort 2 (Tumor Response Analysis Set)
    regimen
    Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00623831-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    harm key
    EG000
    source section id
    NCT00623831-ae
    event group key
    EG000
    event group label
    Cohort 1
    serious affected
    1
    serious at risk
    13
    other affected
    13
    other at risk
    13
    frequency threshold
    0
    collection period
    All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 3 months for each subject.
    event definition
    AE documentation included onset/resolution dates, severity using NCI CTCAE (v3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
    undenominated note
    Source null
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    harm key
    EG001
    source section id
    NCT00623831-ae
    event group key
    EG001
    event group label
    Cohort 2
    serious affected
    1
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    collection period
    All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 3 months for each subject.
    event definition
    AE documentation included onset/resolution dates, severity using NCI CTCAE (v3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00623831
    qol key
    qol-0002
    source section id
    NCT00623831-om-0002
    source outcome index
    2
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Number of Participants With Serum NY-ESO-1-specific Immune Responses
    measure definition
    Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]
    time frame
    Up to 3 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.
    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