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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00467051 |
Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor |
Biological: filgrastim Drug: carboplatin Drug: ifosfamide Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 counts return 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.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:
Meets 1 of the following disease criteria:
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 66 Study Locations| Study Chair: | Carlos Rodriguez-Galindo, MD | St. Jude Children's Research Hospital |
| Investigator: | A. Lindsay Frazier, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000542424, COG-AGCT0521 |
| Study First Received: | April 25, 2007 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00467051 History of Changes |
| Health Authority: | Unspecified |
|
recurrent childhood malignant 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 recurrent ovarian germ cell tumor testicular choriocarcinoma and embryonal carcinoma |
testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular yolk sac tumor recurrent malignant testicular germ cell tumor ovarian yolk sac tumor childhood extracranial germ cell tumor |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Antimitotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Ifosfamide Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Isophosphamide mustard |