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 States20 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 range21 Years
SexALL
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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)
…
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)