Overview

This trial is active, not recruiting.

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
Treatments paclitaxel, carboplatin, ifosfamide, filgrastim, laboratory biomarker analysis
Phase phase 2
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2007
End date March 2012
Trial size 20 participants
Trial identifier NCT00467051, AGCT0521, CDR0000542424, COG-AGCT0521, NCI-2009-00374, U10CA098543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Anzatax
Given IV dosage 135 mg/m2/dose
carboplatin Carboplat
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 Cyfos
Given IV dosage 1800 mg/m2/dose
filgrastim G-CSF
Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis
Optional correlative studies

Primary Outcomes

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

Measure
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

Eligibility Criteria

Male or female participants up to 21 years old.

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 Central Nervous System (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

Additional Information

Official title Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
Principal investigator Carlos Rodriguez-Galindo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.