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NCT00467051 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-08-29

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements: * Yolk sac tumor (endodermal sinus tumor) * Choriocarcinoma * Embryonal carcinoma * Meets 1 of the following disease criteria: * Recurrent malignant disease * Chemotherapy-resistant disease * Relapsed disease * Disease refractory to conventional therapy * Measurable disease * Must have received a prior first-line chemotherapy regimen that included cisplatin * Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible\* * Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible * Karnofsky performance status (PS) 50-100% (age \> 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2 * Life expectancy ≥ 8 weeks * Absolute neutrophil count ≥ 750/mm³ * Platelet count ≥ 75,000/mm³ (transfusion independent) * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following: * ≤ 0.4 mg/dL (1 month to \< 6 months of age) * ≤ 0.5 mg/dL (6 months to \< 1 year of age) * ≤ 0.6 mg/dL (1 to \< 2 years of age) * ≤ 0.8 mg/dL (2 to \< 6 years of age) * ≤ 1.0 mg/dL (6 to \< 10 years of age) * ≤ 1.2 mg/dL (10 to \< 13 years of age) * ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female) * ≤ 1.5 mg/dL (13 to \< 16 years of age) (male) * ≤ 1.7 mg/dL (≥ 16 years of age) (male) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * ALT \< 2.5 times ULN for age * Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study * No dyspnea at rest * No exercise intolerance * Pulse oximetry \> 94% (if there is clinical indication for determination) * Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled * No CNS toxicity \> grade 2 * No active graft-versus-host disease * No allergy to Cremophor EL or castor oil * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent chemotherapy or immunomodulating agents * Recovered from prior chemotherapy, immunotherapy, or radiotherapy * At least 1 week since prior growth factors (2 weeks for pegfilgrastim) * At least 1 week since prior biologic therapy * At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) * At least 2 weeks since prior local palliative radiotherapy (i.e., small port) * At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * At least 6 months since prior allogeneic stem cell transplantation * Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Carboplatin
    2. Biological: Filgrastim
    3. Drug: Ifosfamide
    4. Other: Laboratory Biomarker Analysis
    5. Drug: Paclitaxel
    label
    Treatment (chemotherapy, biological therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carbosin
    6. Carbosol
    7. Carbotec
    8. CBDCA
    9. Displata
    10. Ercar
    11. JM-8
    12. Nealorin
    type
    DRUG
  2. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Given IV or subcutaneously
    name
    Filgrastim
    other Names
    1. FILGRASTIM, LICENSE HOLDER UNSPECIFIED
    2. G-CSF
    3. Neupogen
    4. r-metHuG-CSF
    5. Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    6. rG-CSF
    7. Tevagrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Given IV
    name
    Ifosfamide
    other Names
    1. Asta Z 4942
    2. Asta Z-4942
    3. Cyfos
    4. Holoxan
    5. Holoxane
    6. Ifex
    7. IFO
    8. IFO-Cell
    9. Ifolem
    10. Ifomida
    11. Ifomide
    12. Ifosfamidum
    type
    DRUG
  4. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Optional correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
    time Frame
    At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
secondary Outcomes
  1. measure
    The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
    time Frame
    Two cycles of chemotherapy; expected to be 42 days of treatment.
Full study description
brief Summary
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin. SECONDARY OBJECTIVES: I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT. OUTLINE: This is a multicenter study. 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. After completion of study treatment, patients are followed periodically for up to 5 years.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        d.[<a href="#cit/section_8.3">3</a>]</p> <p id="_730" tabindex="-1">In a phase II Children&#8217;s Oncology Group (COG) trial (<a href="/clinicaltrials/NCT00467051">AGCT0521 [NCT00467051]</a>), 20 patients younger than 21 years who relapsed after PEb therapy received two cycles of paclitaxel, ifosfamide, and carboplatin (
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      2. context exact
        n_8.3">3</a>]</p> <p id="_730" tabindex="-1">In a phase II Children&#8217;s Oncology Group (COG) trial (<a href="/clinicaltrials/NCT00467051">AGCT0521 [NCT00467051]</a>), 20 patients younger than 21 years who relapsed after PEb therapy received two cycles of paclitaxel, ifosfamide, and carboplatin (TIC). Responses were th
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      source file
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      source retrieved at
      2026-09-09T23:21:40.557353+00:00
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      source string sha256
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      source title
      Childhood Extracranial Germ Cell Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: November 5, 2024
        datetime
        2024-11-05T12:00:00Z
        display
        November 5, 2024

    Preserved source evidence · Not medical advice