Ovarian Cancer Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 21 Years |
Eligibility |
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 allowed |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Widemann 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose and dose-limiting toxicity of ixabepilone | Yes | ||
Primary | Toxicity spectrum | Yes | ||
Primary | Plasma pharmacokinetics | No | ||
Primary | Pharmacodynamics | No | ||
Primary | Nerve growth factor levels before and after drug administration | No | ||
Secondary | Objective tumor response | No | ||
Secondary | 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 | No |
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