Clinical trial · Interventional
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
NCT00467051CI-TRIAL-00034642completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Extracranial Germ Cell Tumor | Childhood Extracranial Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Extragonadal Malignant Germ Cell Tumor | Childhood Malignant Extragonadal Germ Cell Tumor | ALIAS | 0.90 |
| Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Malignant Testicular Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Choriocarcinoma | Ovarian Choriocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Embryonal Carcinoma | Ovarian Embryonal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Yolk Sac Tumor | Ovarian Yolk Sac Tumor | ONTOLOGY_EXACT | 0.98 |
| Recurrent Childhood Malignant Germ Cell Tumor | Childhood Malignant Germ Cell Tumor |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, biological therapy)
- description
- 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.
- interventionNames
- Drug: Carboplatin
- Biological: Filgrastim
- Drug: Ifosfamide
- Other: Laboratory Biomarker Analysis
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- 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)
- description
- Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available
No reference posted for this study.