Clinical trial · Interventional
Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Therapy
Phase I Trial and Pharmacokinetic Study of BMS-247550 (NSC 710428, Ixabepilone), an Epothilone B Analog, in Pediatric Patients With Refractory Solid Tumors and Leukemias
- 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. PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia.
Conditions
Conditions (10)
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 | — |
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Maximum tolerated dose and dose-limiting toxicity of ixabepilone
- measure
- Toxicity spectrum
- measure
- Plasma pharmacokinetics
- measure
- Pharmacodynamics
- measure
- Nerve growth factor levels before and after drug administration
Secondary outcomes (2)
- measure
- Objective tumor response
- measure
- Tubulin polymerization in PBMCs prior to the start of the infusion, just before the end of the infusion, 5 hours after the end of the infusion and before the start of the infusion on day 2 of the ixabepilone on course 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Meets 1 of the following criteria:
* Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist
* Curative therapy may include surgery, radiotherapy, chemotherapy, or any combination of these modalities
* Eligible tumor types include, but are not limited to, the following:
* Rhabdomyosarcoma
* Other soft tissue sarcomas
* Ewing's sarcoma family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumors
* Histologic confirmation may be waived for brain stem or optic glioma
* Diagnosis of relapsed or refractory leukemia
* Patients with refractory or second or greater relapsed leukemia must have \> 25% blasts in the bone marrow (M3 bone marrow) with or without active extramedullary disease (except for leptomeningeal disease)
* Relapsed after or failed to respond to frontline curative therapy and no other potentially curative therapy (e.g., radiotherapy, chemotherapy, or any combination of these modalities) exists
* Patients with acute promyelocytic leukemia must be refractory to treatment with retinoic acid and arsenic trioxide
* Patients with Philadelphia chromosome positive chronic myelogenous leukemia must be refractory to imatinib
* No active CNS leukemia (CNS3)
PATIENT CHARACTERISTICS:
Age:
* 2 to 18 (solid tumor patients \[closed to accrual as of 10/4/2007\])
* 1 to 21 (leukemia patients)
Performance status:
* For patients age 11 to 21:
* Karnofsky 50-100%
* For patients age 1 to 10:
* Lansky 50-100%
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm\^3 (20,000/mm\^3 for leukemia patients)
* Hemoglobin ≥ 8.0 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* No hepatic dysfunction that would preclude study
Renal:
* Creatinine normal for age OR
* Creatinine clearance at least 60 mL/min
* No renal dysfunction that would preclude study
Other:
* No known severe prior hypersensitivity reaction to agents containing Cremophor EL
* No clinically significant unrelated systemic illness (e.g., serious infections or other organ dysfunction) that would preclude study
* No grade 2 or greater preexisting sensory neuropathy
* More than 2 month since prior and no concurrent evidence of graft vs host disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Recovered from all therapy-related acute toxic effects (leukemia patients only)
* Prior epoetin alfa allowed
* At least 3 days since other prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (IL-11))
* At least 6 months since prior bone marrow transplantation
* At least 2 months since prior stem cell transplantation or rescue (leukemia patients)
* At least 7 days since prior therapy with a biological agent and hematopoietic growth factor with the exception of erythropoietin
* More than 3 weeks since prior monoclonal antibody therapy (leukemia patients only)
* No concurrent GM-CSF or IL-11
* No concurrent immunotherapy
Chemotherapy:
* See Disease Characteristics
* Recovered from all therapy-related acute toxic effects (leukemia patients only)
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* Concurrent corticosteroids allowed for the control of symptoms related to tumor-associated edema in patients with brain tumors
* Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan is performed for the purpose of assessing response to study therapy
* Must be on a stable or tapering dose of corticosteroids for 7 days prior to study entry (leukemia patients only)
Radiotherapy:
* See Disease Characteristics
* Recovered from all therapy-related acute toxic effects (leukemia patients only)
* At least 4 weeks since prior radiotherapy
* More than 2 weeks since prior local palliative radiotherapy (leukemia patients only)
* More than 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥50% of the pelvis (leukemia patients only)
* More than 6 weeks since prior other substantial bone marrow radiotherapy (leukemia patients only)
* No prior extensive radiotherapy (e.g., craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis)
* No concurrent anticancer radiotherapy
Surgery:
* See Disease Characteristics
Other:
* Recovered from prior therapy
* At least 30 days since any prior investigational anticancer therapy
* At least 1 week since prior known inhibitors of CYP3A4, including any of the following:
* Antibiotics (i.e., clarithromycin, erythromycin, or troleandomycin)
* Anti-HIV agents (i.e, delaviridine, nelfinavir, amprenavir, ritonavir, idinavir, saquinavir, or lopinavir)
* Anti-fungals (i.e., itraconazole, ketoconazole, fluconazole \[doses \> 3mg/kg/day\], or voriconazole)
* Anti-depressants (i.e., nefaxodone or fluovoxamine)
* Calcium channel blockers (i.e., verapamil or diltiazem)
* Anti-emetics (i.e., aprepitant \[Emend®\])
* Miscellaneous agents (i.e., amiodarone)
* Grapefruit juice
* No other concurrent investigational agents
* No concurrent St. John's Wort
* No concurrent known inhibitors of CYP3A4, including grapefruit juice
* Concurrent other agents inducing CYP3A4 allowedReferences
Publications (1)
- RESULTWidemann BC, Goodspeed W, Goodwin A, Fojo T, Balis FM, Fox E. Phase I trial and pharmacokinetic study of ixabepilone administered daily for 5 days in children and adolescents with refractory solid tumors. J Clin Oncol. 2009 Feb 1;27(4):550-6. doi: 10.1200/JCO.2008.17.6644. Epub 2008 Dec 15. PMID 19075272