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

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ClinicalTrials.gov Identifier: NCT00467051

Recruitment Status : Completed

First Posted : April 27, 2007

Results First Posted : March 20, 2015

Last Update Posted : August 29, 2018

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Malignant 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 Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor Testicular Yolk Sac Tumor
Interventions	Drug: Carboplatin Biological: Filgrastim Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Paclitaxel
Enrollment	20

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Treatment (Chemotherapy, Biological Therapy)
Arm/Group Description	Patients receive paclitaxel IV over...
Arm/Group 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. 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
Period Title: Overall Study
Started	20
Completed	18
Not Completed	2
Reason Not Completed
Adverse Event	2

Baseline Characteristics

Arm/Group Title		Treatment (Chemotherapy, Biological Therapy)
Arm/Group Description		Patients receive paclitaxel IV over...
Arm/Group 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. 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
Overall Number of Baseline Participants		20
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants
	<=18 years	20 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	20 participants
		13.5 (1 to 18)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants
	Female	8 40.0%
	Male	12 60.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants
	Hispanic or Latino	8 40.0%
	Not Hispanic or Latino	11 55.0%
	Unknown or Not Reported	1 5.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants
	American Indian or Alaska Native	0 0.0%
	Asian	1 5.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 5.0%
	White	14 70.0%
	More than one race	0 0.0%
	Unknown or Not Reported	4 20.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	20 participants
United States		15
Canada		3
Australia		1
Puerto Rico		1

Outcome Measures

1.Primary Outcome


Title	Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Description	Patients who demonstrate a PR or CR, as defined below, will be conside...
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.
Time Frame	At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Chemotherapy, Biological Therapy)
Arm/Group Description:	Patients receive paclitaxel IV over...
Arm/Group 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. 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
Overall Number of Participants Analyzed	20
Measure Type: Number Unit of Measure: participants
Responder	12
Non-Responder	8

2.Secondary Outcome


Title	The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Two cycles of chemotherapy; expected to be 42 days of treatment.

Outcome Measure Data

Analysis Population Description

All eligible patients.


Arm/Group Title	Experimental
Arm/Group Description:	[Not Specified]
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	20
Measure Type: Count of Participants Unit of Measure: Participants
	18 90.0%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	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.

Arm/Group Title	Treatment (Chemotherapy, Biological Therapy)
Arm/Group Description	Patients receive paclitaxel IV over...
Arm/Group 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. 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
All-Cause Mortality
	Treatment (Chemotherapy, Biological Therapy)
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Treatment (Chemotherapy, Biological Therapy)
	Affected / at Risk (%)
Total	0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment (Chemotherapy, Biological Therapy)
	Affected / at Risk (%)
Total	18/20 (90.00%)
Blood and lymphatic system disorders
Anemia	8/20 (40.00%)
Blood and lymphatic system disorders - Other	1/20 (5.00%)
Febrile neutropenia	5/20 (25.00%)
Cardiac disorders
Cardiac disorders - Other	1/20 (5.00%)
Gastrointestinal disorders
Oral hemorrhage	1/20 (5.00%)
Vomiting	2/20 (10.00%)
Infections and infestations
Bladder infection	1/20 (5.00%)
Infections and infestations - Other	4/20 (20.00%)
Investigations
Alanine aminotransferase increased	2/20 (10.00%)
Aspartate aminotransferase increased	1/20 (5.00%)
Lymphocyte count decreased	5/20 (25.00%)
Neutrophil count decreased	12/20 (60.00%)
Platelet count decreased	9/20 (45.00%)
White blood cell decreased	14/20 (70.00%)
Metabolism and nutrition disorders
Hyperglycemia	1/20 (5.00%)
Hypokalemia	3/20 (15.00%)
Hyponatremia	2/20 (10.00%)
Hypophosphatemia	1/20 (5.00%)
Nervous system disorders
Ataxia	1/20 (5.00%)
Intracranial hemorrhage	1/20 (5.00%)
Nervous system disorders - Other	1/20 (5.00%)
Psychiatric disorders
Agitation	1/20 (5.00%)
Confusion	1/20 (5.00%)
Skin and subcutaneous tissue disorders
Nail loss	1/20 (5.00%)
Vascular disorders
Hypotension	1/20 (5.00%)

Limitations and Caveats

[Not Specified]

More Information

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.

Must obtain prior Sponsor approval.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Results Reporting Coordinator
Organization:	Children's Oncology Group
Phone:	626-447-0064
EMail:	resultsreportingcoordinator@childrensoncologygroup.org

Layout table for additonal information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00467051
Other Study ID Numbers:	AGCT0521 NCI-2009-00374 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-AGCT0521 CDR0000542424 AGCT0521 ( Other Identifier: Childrens Oncology Group ) AGCT0521 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted:	April 25, 2007
First Posted:	April 27, 2007
Results First Submitted:	March 11, 2015
Results First Posted:	March 20, 2015
Last Update Posted:	August 29, 2018

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