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← Childhood Soft Tissue Sarcoma

NCT00831844 · STUDY IN CONTEXT

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

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

Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).

Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-pediatric
nct id
NCT00831844
trial label
Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
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
1
harms Count
10
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    source section id
    NCT00831844-om-0000
    source outcome index
    0
    endpoint
    Disease Response
    endpoint definition
    Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).
    time origin
    First six treatment cycles - 24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group 1 - Recurrent or Refractory Hepatoblastoma
    regimen
    Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Group 2 - Recurrent or Refractory Synovial Sarcoma
    regimen
    Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma
    regimen
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
    regimen
    Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    regimen
    Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
    regimen
    Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG006
    arm label
    Grp 7-Neuroblastoma With Measurable Disease
    regimen
    Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG007
    arm label
    Group 8 - Recurrent Osteosarcoma
    regimen
    Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG008
    arm label
    Group 9 - Recurrent or Refractory Wilms Tumor
    regimen
    Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    outcome key
    om-0000
    arm key
    OG009
    arm label
    Group 10 - Recurrent or Refractory Retinoblastoma
    regimen
    Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00831844-om-0000#groups/OG009
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG000
    source section id
    NCT00831844-ae
    event group key
    EG000
    event group label
    Group 1 - Recurrent or Refractory Hepatoblastoma
    serious affected
    7
    serious at risk
    10
    other affected
    5
    other at risk
    10
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG001
    source section id
    NCT00831844-ae
    event group key
    EG001
    event group label
    Group 2 - Recurrent or Refractory Synovial Sarcoma
    serious affected
    3
    serious at risk
    10
    other affected
    7
    other at risk
    10
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG002
    source section id
    NCT00831844-ae
    event group key
    EG002
    event group label
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma
    serious affected
    4
    serious at risk
    20
    other affected
    14
    other at risk
    20
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG003
    source section id
    NCT00831844-ae
    event group key
    EG003
    event group label
    Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
    serious affected
    5
    serious at risk
    10
    other affected
    5
    other at risk
    10
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG004
    source section id
    NCT00831844-ae
    event group key
    EG004
    event group label
    Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    serious affected
    5
    serious at risk
    13
    other affected
    8
    other at risk
    13
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    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-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG005
    source section id
    NCT00831844-ae
    event group key
    EG005
    event group label
    Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
    serious affected
    5
    serious at risk
    20
    other affected
    9
    other at risk
    20
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG006
    source section id
    NCT00831844-ae
    event group key
    EG006
    event group label
    Grp 7-Neuroblastoma With Measurable Disease
    serious affected
    4
    serious at risk
    10
    other affected
    9
    other at risk
    10
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG007
    source section id
    NCT00831844-ae
    event group key
    EG007
    event group label
    Group 8 - Recurrent Osteosarcoma
    serious affected
    4
    serious at risk
    9
    other affected
    5
    other at risk
    9
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG008
    source section id
    NCT00831844-ae
    event group key
    EG008
    event group label
    Group 9 - Recurrent or Refractory Wilms Tumor
    serious affected
    5
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma-pediatric
    nct id
    NCT00831844
    harm key
    EG009
    source section id
    NCT00831844-ae
    event group key
    EG009
    event group label
    Group 10 - Recurrent or Refractory Retinoblastoma
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    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
    setting source links

      Preserved source evidence · Not medical advice