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Investigator(s):
Elizabeth Fox, M.D. Principal Investigator Phone: 301-402-6641 foxb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically confirmed diagnosis of one of the following:
• Recurrent or refractory malignant extracranial solid tumor with measurable or evaluable disease (bone marrow metastasis allowed if not refractory to red cell or platelet transfusion)
• Imatinib-resistant Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia or chronic myelogenous leukemia with measurable disease
• > 12 months and ≤ 21 years of age
• No CNS solid tumors; CNS positive leukemia allowed
• Must have recovered from prior therapy
• ≥ 3 months since stem cell transplant; no evidence of graft vs. host disease
• Karnofsky performance status (PS) ≥ 50% for patients > 10 years of age; Lansky PS ≥ 50% for patients ≤ 10 years of age
• Patients with solid tumors:
• ANC ≥ 1,000/mm³ (750/mm³ if bone marrow infiltration)
• Platelet count ≥ 100,000/mm³ (transfusion independent) (50,000/mm³ if bone marrow infiltration)
• Hemoglobin ≥ 8.0 g/dL (red blood cell [RBC] transfusions allowed)
• Patients with leukemia:
• Platelet count ≥ 20,000/mm³ (platelet transfusions allowed)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
• Creatinine normal for age or creatinine clearance or radioisotope GFR ≥ 70 mL/min
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• ALT ≤ 110 U/L
• Albumin ≥ 2 g/dL
• Normal 12-lead EKG with corrected QTc < 450 msec plus either normal shortening fraction or normal ejection fraction
• No evidence of dyspnea at rest
• No exercise intolerance
• Pulse oximetry > 94%
• Not pregnant or nursing; fertile patients must use effective contraception
• No uncontrolled infection
• Must be able to swallow oral or liquid medication
• No other investigational agents, other anti-cancer agents (except for IT therapy for patients with CNS-positive leukemia), enzyme inducing anti-convulsants, antithrombotic or antiplatelet agents, CYP3A4 inhibitors or antiretroviral therapy

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Treatment Plan:

This is a multicenter, dose-escalation study. Patients are stratified according to disease.

Arm I (Solid Tumors)

• Patients receive oral dasatinib twice daily on days 1–28
• Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
• Cohorts of 3–6 patients receive escalating doses of dasatinib until the maximum tolerated dose (MTD) is determined; the MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity (DLT)

Arm II (Leukemia)

• Patients receive oral dasatinib twice daily on Days 1–28
• Treatment repeats every 28 days for up to 24 courses in the absence of disease
• Patients with imatinib-resistant Philadelphia positive leukemia will start at the 50mg/m² dose and will dose escalate one dose level below the dose level under study in solid tumor patients
• Cohorts of 3–12 patients receive escalating or de-escalating doses of dasatinib; the MTD is defined as the dose preceding that at which 7 of 12 patients experience DLT

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/17/08
Updated: 11/12/08