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← Recurrent Childhood Malignant Germ Cell Tumor

NCT00467051 · STUDY IN CONTEXT

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell 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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.

Source null

→

secondary · POSTED

The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.

All eligible patients.

→

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-recurrent-childhood-malignant-germ-cell-tumor
nct id
NCT00467051
trial label
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell 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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-recurrent-childhood-malignant-germ-cell-tumor
    nct id
    NCT00467051
    outcome key
    om-0000
    source section id
    NCT00467051-om-0000
    source outcome index
    0
    endpoint
    Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
    endpoint definition
    Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
    time origin
    At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-recurrent-childhood-malignant-germ-cell-tumor
    nct id
    NCT00467051
    outcome key
    om-0001
    source section id
    NCT00467051-om-0001
    source outcome index
    1
    endpoint
    The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
    endpoint definition
    The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
    time origin
    Two cycles of chemotherapy; expected to be 42 days of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients.
    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-recurrent-childhood-malignant-germ-cell-tumor
    nct id
    NCT00467051
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Biological Therapy)
    regimen
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00467051-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-recurrent-childhood-malignant-germ-cell-tumor
    nct id
    NCT00467051
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Experimental
    regimen
    Experimental
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00467051-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-recurrent-childhood-malignant-germ-cell-tumor
    nct id
    NCT00467051
    harm key
    EG000
    source section id
    NCT00467051-ae
    event group key
    EG000
    event group label
    Treatment (Chemotherapy, Biological Therapy)
    serious affected
    0
    serious at risk
    20
    other affected
    18
    other at risk
    20
    frequency threshold
    0
    collection period
    Source null
    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