Clinical trial · Interventional
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL
NCT00070096CI-TRIAL-00010978completedPhase 2ClinicalTrials.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, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.
Conditions
Conditions (4)
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 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Efficacy
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
* Measurable metastatic disease by one of the following methods:
* Radiography
* If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
* Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
* Previously treated progressive disease meeting 1 of the following criteria:
* Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
* Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
* Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)
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 greater than 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 2 times upper limit of normal
Renal
* Creatinine no greater than 2.2 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* No other concurrent cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No other concurrent experimental or commercial anticancer medications or therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.