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NCT00831844 · OUTCOME

Disease Response

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors · Source last updated 2015-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
patient
Interval / dispersion
Not reported
Time frame
First six treatment cycles - 24 weeks

What was measured

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

Analysis population: 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).

Groups in this outcome

Group 1 - Recurrent or Refractory Hepatoblastoma

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

Group 2 - Recurrent or Refractory Synovial Sarcoma

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

Group 3 - Recurrent or Refractory Rhabdomyosarcoma

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

Grp 4-Recurrent or Refractory Adrenocortical Carcinoma

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

Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

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

Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease

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

Grp 7-Neuroblastoma With Measurable Disease

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

Group 8 - Recurrent Osteosarcoma

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

Group 9 - Recurrent or Refractory Wilms Tumor

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

Group 10 - Recurrent or Refractory Retinoblastoma

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 1 - Recurrent or Refractory Hepatoblastoma10
Group 2 - Recurrent or Refractory Synovial Sarcoma10
Group 3 - Recurrent or Refractory Rhabdomyosarcoma20
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma10
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor13
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease20
Grp 7-Neuroblastoma With Measurable Disease10
Group 8 - Recurrent Osteosarcoma9
Group 9 - Recurrent or Refractory Wilms Tumor9
Group 10 - Recurrent or Refractory Retinoblastoma0

Reported measurements

Non-Responder
Values in patient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 - Recurrent or Refractory Hepatoblastoma10Not reportedNot reportedNot reportedNot reported
Group 2 - Recurrent or Refractory Synovial Sarcoma10Not reportedNot reportedNot reportedNot reported
Group 3 - Recurrent or Refractory Rhabdomyosarcoma19Not reportedNot reportedNot reportedNot reported
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma10Not reportedNot reportedNot reportedNot reported
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor11Not reportedNot reportedNot reportedNot reported
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease16Not reportedNot reportedNot reportedNot reported
Grp 7-Neuroblastoma With Measurable Disease10Not reportedNot reportedNot reportedNot reported
Group 8 - Recurrent Osteosarcoma9Not reportedNot reportedNot reportedNot reported
Group 9 - Recurrent or Refractory Wilms Tumor9Not reportedNot reportedNot reportedNot reported
Responder
Values in patient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 - Recurrent or Refractory Hepatoblastoma0Not reportedNot reportedNot reportedNot reported
Group 2 - Recurrent or Refractory Synovial Sarcoma0Not reportedNot reportedNot reportedNot reported
Group 3 - Recurrent or Refractory Rhabdomyosarcoma1Not reportedNot reportedNot reportedNot reported
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma0Not reportedNot reportedNot reportedNot reported
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor2Not reportedNot reportedNot reportedNot reported
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease4Not reportedNot reportedNot reportedNot reported
Grp 7-Neuroblastoma With Measurable Disease0Not reportedNot reportedNot reportedNot reported
Group 8 - Recurrent Osteosarcoma0Not reportedNot reportedNot reportedNot reported
Group 9 - Recurrent or Refractory Wilms Tumor0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        19
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        16
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        9
      9. group Id
        OG008
        value
        9
    title
    Non-Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      20
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      0
    units
    Participants
description
Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).
groups
  1. description
    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
    id
    OG000
    title
    Group 1 - Recurrent or Refractory Hepatoblastoma
  2. description
    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
    id
    OG001
    title
    Group 2 - Recurrent or Refractory Synovial Sarcoma
  3. description
    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
    id
    OG002
    title
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma
  4. description
    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
    id
    OG003
    title
    Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
  5. description
    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
    id
    OG004
    title
    Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  6. description
    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
    id
    OG005
    title
    Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
  7. description
    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
    id
    OG006
    title
    Grp 7-Neuroblastoma With Measurable Disease
  8. description
    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
    id
    OG007
    title
    Group 8 - Recurrent Osteosarcoma
  9. description
    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
    id
    OG008
    title
    Group 9 - Recurrent or Refractory Wilms Tumor
  10. description
    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
    id
    OG009
    title
    Group 10 - Recurrent or Refractory Retinoblastoma
param Type
NUMBER
population Description
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).
reporting Status
POSTED
time Frame
First six treatment cycles - 24 weeks
title
Disease Response
type
PRIMARY
unit Of Measure
patient

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice