Status:
COMPLETED
Dasatinib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Blastic Phase Chronic Myelogenous Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of dasatinib in treating young patients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acute lymphoblastic ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the toxicities and estimate the maximum tolerated dose or the recommended phase 2 dose of dasatinib in pediatric patients with refractory solid tumors. II. Determine...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed diagnosis of 1 of the following:
- Malignant extracranial solid tumor
- Recurrent or refractory disease
- Known bone marrow metastases\* allowed
- Imatinib mesylate-resistant Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), defined as M3 bone marrow in a patient who previously received imatinib mesylate-containing treatment regimen
- Imatinib mesylate-resistant Ph+ chronic myelogenous leukemia (CML), as defined by any of the following:
- Increasing WBC or platelet count while on imatinib mesylate therapy
- Lack of any cytogenetic response after an adequate duration of imatinib mesylate therapy, as defined by 1 of the following:
- Failed to achieve a complete hematologic response after completion of 3 months of imatinib mesylate treatment
- Failed to achieve a partial or complete cytogenetic response (i.e., ≤ 35% Ph+ cells) after 6 months of imatinib mesylate treatment
- Appearance of accelerated or blastic feature while on imatinib mesylate therapy
- Reappearance of Ph+ clones after an initial complete cytogenetic response to imatinib mesylate
- More than 30% increase in Ph+ cells in peripheral blood or bone marrow cytogenetics while on imatinib mesylate therapy
- Imatinib mesylate intolerance, as defined by development of adverse effects requiring discontinuation of imatinib mesylate therapy
- Measurable disease (for patients with CML or ALL)
- Determined by hematologic, cytogenetic, and molecular studies for CML
- Determined by bone marrow blast percentage for ALL
- Measurable or evaluable disease (for patients with solid tumors)
- No known curative therapy or survival-prolonging therapy with an acceptable quality of life
- No CNS solid tumors
- CNS-positive leukemia allowed
- Karnofsky performance status (PS) ≥ 50% (for patients \> 10 years of age)
- Lansky PS ≥ 50% (for patients ≤ 10 years of age)
- No evidence of graft-vs-host disease
- Solid tumors:
- Absolute neutrophil count ≥ 1,000/mm\^3 (750/mm\^3 if bone marrow infiltration)
- Platelet count ≥ 100,000/mm\^3 (transfusion independent) (50,000/mm\^3 if bone marrow infiltration)
- Hemoglobin ≥ 8.0 g/dL (red blood cell \[RBC\] transfusions allowed)
- ALL/CML:
- Platelet count ≥ 20,000/mm\^3 (platelet transfusions allowed)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age, as follows:
- No greater than 0.6 mg/dL (1-23 months of age)
- No greater than 0.8 mg/dL (2- 5 years of age)
- No greater than 1.0 mg/dL (6-9 years of age)
- No greater than 1.2 mg/dL (10-12 years of age)
- No greater than 1.4 mg/dL (13 years of age and over \[female\])
- No greater than 1.5 mg/dL (13-15 years of age \[male\])
- No greater than 1.7 mg/dL (16 years of age and over \[male\])
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 110 U/L
- Albumin ≥ 2 g/dL
- Normal 12-lead EKG with corrected QTc \< 450 msec AND meets 1 of the following criteria:
- Shortening fraction normal
- Ejection fraction normal
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry \> 94% if there is a clinical indication for determination
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No swallowing dysfunction that would prevent taking an oral or liquid medication
- See Disease Characteristics
- Recovered from prior chemotherapy, immunotherapy, or radiotherapy
- No myelosuppressive chemotherapy within the past 3 weeks (6 weeks for nitrosoureas)
- At least 7 days since prior growth factors
- At least 14 days since prior pegfilgrastim
- At least 7 days since prior biologic agents
- At least 2 weeks since prior local small-port palliative radiotherapy
- At least 3 months since prior total-body irradiation, craniospinal radiation, or radiation to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiation
- At least 3 months since prior stem cell transplantation
- Hydroxyurea cytoreduction for Ph+ leukemia allowed provided it is discontinued 24 hours before first dose of dasatinib
- Prior intrathecal (IT) therapy allowed (for patients with CNS-positive leukemia)
- Concurrent IT therapy comprising hydrocortisone, cytarabine, methotrexate, or cytarabine (liposomal) allowed (for patients with CNS-positive leukemia)
- No other concurrent investigational drugs
- No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
- No concurrent enzyme-inducing anticonvulsants, including any of the following:
- Phenytoin
- Phenobarbital
- Carbamazepine
- Felbamate
- Primdone
- Oxcarbazepine
- No concurrent antithrombotic or antiplatelet agents, including any of the following:
- Warfarin
- Heparin
- Low-molecular weight heparin
- Aspirin
- Ibuprofen
- Other nonsteroidal anti-inflammatory drugs
- No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, and voriconazole
- No concurrent highly active antiretroviral treatment for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00316953
Start Date
March 1 2006
Last Update
February 5 2013
Active Locations (1)
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1
Children's Oncology Group
Arcadia, California, United States, 91006-3776