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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00467051

Run by

Children's Oncology Group

People needed

20

Starts

2007-11-05

Expected to finish

2018-06-30

Last updated by the study team

2018-08-29

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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