Clinical trial · Interventional
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
NCT00002931CI-TRIAL-00026103completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Teratoma | Teratoma | ONTOLOGY_EXACT | 0.90 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HD Chemo and Auto Stem Cells
- interventionNames
- Biological: filgrastim
- Drug: carboplatin
- Drug: etoposide
- Drug: ifosfamide
- Drug: paclitaxel
- Procedure: autologous bone marrow transplantation
- Procedure: bone marrow ablation with stem cell support
Primary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
- Until disease progression, up to 5 years.
- description
- Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
- measure
- Toxic Effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category * Bidimensionally measurable disease with measurements performed within 21 days of study entry * Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.6 mg/dL * SGOT and SGPT no greater than 2 times upper limit of normal (ULN) * No active hepatitis or cirrhosis Renal: * Creatinine clearance at least 70 mL/min Cardiovascular: * Ejection fraction (MUGA or echocardiogram) normal * No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment Pulmonary: * PaO\_2 at least 70 mm Hg * FEV\_1 at least 2 L or 75% * No history of bleomycin associated or serious lung disease Neurologic: * No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study * Prior peripheral neuropathy requires consultation with principal investigator Other: * No significant active medical illness precluding study or survival * Not HIV positive * No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer * No prior hematologic malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or stem cell rescue with high-dose chemotherapy Chemotherapy: * Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue * No prior paclitaxel Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy during study Surgery: * Recovered from prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.