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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00467051
First received: April 25, 2007
Last updated: March 18, 2014
Last verified: March 2014

April 25, 2007
March 18, 2014
November 2007
March 2012   (final data collection date for primary outcome measure)
Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: At baseline and after completion of protocol therapy ] [ Designated as safety issue: No ]
Confidence intervals will be constructed according to the method of Chang and O'Brien.
Response as measured by RECIST
Complete list of historical versions of study NCT00467051 on ClinicalTrials.gov Archive Site
Toxicity as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) version 4.0 [ Time Frame: During and after completion of study treatment ] [ Designated as safety issue: Yes ]
All patients who experience any grade 2 or higher toxicity at any time during the two treatment cycles or who receive at least all required Ifosfamide therapy after enrollment will be considered evaluable for toxicity. The descriptions and grading scales found in the revised NCI CTCAE version 4 will be used.
Toxicity as measured by NCI CTCAE v3.0
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Childhood Extracranial Germ Cell Tumor
  • Childhood Extragonadal Germ Cell Tumor
  • Childhood Malignant Ovarian Germ Cell Tumor
  • Childhood Malignant Testicular Germ Cell Tumor
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Yolk Sac Tumor
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Malignant Testicular Germ Cell Tumor
  • Recurrent Ovarian Germ Cell Tumor
  • Testicular Choriocarcinoma
  • Testicular Choriocarcinoma and Embryonal Carcinoma
  • Testicular Choriocarcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma
  • Testicular Embryonal Carcinoma and Yolk Sac Tumor
  • Testicular Yolk Sac Tumor
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Drug: ifosfamide
    Given IV
    Other Names:
    • Cyfos
    • Holoxan
    • IFF
    • IFX
    • IPP
  • Biological: filgrastim
    Given IV or subcutaneously
    Other Names:
    • G-CSF
    • Neupogen
  • Other: laboratory biomarker analysis
    Optional correlative studies
Experimental: Treatment (chemotherapy, biological therapy)
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.
Interventions:
  • Drug: paclitaxel
  • Drug: carboplatin
  • Drug: ifosfamide
  • Biological: filgrastim
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
March 2012   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Puerto Rico
 
NCT00467051
AGCT0521, NCI-2009-00374, COG-AGCT0521, CDR0000542424, U10CA098543
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Carlos Rodriguez-Galindo Children's Oncology Group
Children's Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP