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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00467051




Registration number
NCT00467051
Ethics application status
Date submitted
25/04/2007
Date registered
27/04/2007
Date last updated
29/08/2018

Titles & IDs
Public title
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
Scientific title
Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
Secondary ID [1] 0 0
NCI-2009-00374
Secondary ID [2] 0 0
AGCT0521
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Extracranial Germ Cell Tumor 0 0
Childhood Extragonadal Malignant Germ Cell Tumor 0 0
Childhood Malignant Ovarian Germ Cell Tumor 0 0
Childhood Malignant Testicular Germ Cell Tumor 0 0
Ovarian Choriocarcinoma 0 0
Ovarian Embryonal Carcinoma 0 0
Ovarian Yolk Sac Tumor 0 0
Recurrent Childhood Malignant Germ Cell Tumor 0 0
Recurrent Malignant Testicular Germ Cell Tumor 0 0
Recurrent Ovarian Germ Cell Tumor 0 0
Testicular Choriocarcinoma 0 0
Testicular Embryonal Carcinoma 0 0
Testicular Mixed Choriocarcinoma and Embryonal Carcinoma 0 0
Testicular Mixed Choriocarcinoma and Yolk Sac Tumor 0 0
Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor 0 0
Testicular Yolk Sac Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Other interventions - Filgrastim
Treatment: Drugs - Ifosfamide
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Paclitaxel

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.


Treatment: Drugs: Carboplatin
Given IV

Other interventions: Filgrastim
Given IV or subcutaneously

Treatment: Drugs: Ifosfamide
Given IV

Other interventions: Laboratory Biomarker Analysis
Optional correlative studies

Treatment: Drugs: Paclitaxel
Given IV

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria - 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.
Timepoint [1] 0 0
At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
Secondary outcome [1] 0 0
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Timepoint [1] 0 0
Two cycles of chemotherapy; expected to be 42 days of treatment.

Eligibility
Key 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
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
North Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
West Virginia
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Manitoba
Country [37] 0 0
Canada
State/province [37] 0 0
Nova Scotia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Puerto Rico
State/province [40] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00467051
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlos Rodriguez-Galindo
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications