Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Ce… (NCT00467051) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
United States, Australia, Canada20 participantsStarted 2007-11-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Timeframe: At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)