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: April 8, 2015
Last verified: April 2015
Results First Received: March 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: 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
Interventions: Drug: paclitaxel
Drug: carboplatin
Drug: ifosfamide
Biological: filgrastim
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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


Participant Flow:   Overall Study
    Treatment (Chemotherapy, Biological Therapy)  
STARTED     20  
COMPLETED     18  
NOT COMPLETED     2  
Adverse Event                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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


Baseline Measures
    Treatment (Chemotherapy, Biological Therapy)  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     20  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Median (Full Range)
  13.5    (1 to 18)  
Gender  
[units: participants]
 
Female     8  
Male     12  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     8  
Not Hispanic or Latino     11  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     14  
More than one race     0  
Unknown or Not Reported     4  
Region of Enrollment  
[units: participants]
 
United States     15  
Canada     3  
Australia     1  
Puerto Rico     1  



  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00467051     History of Changes
Other Study ID Numbers: AGCT0521, NCI-2009-00374, COG-AGCT0521, CDR0000542424, U10CA098543
Study First Received: April 25, 2007
Results First Received: March 11, 2015
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration