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

Not Recruiting

Trial ID: NCT00316953


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 leukemia or chronic myelogenous leukemia that did not respond to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Official Title

A Phase I Study of BMS-354825 (Dasatinib) in Children With Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia (BMS Trial CA180038)

Stanford Investigator(s)


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

         - 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

   - 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

      - 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

   - No concurrent highly active antiretroviral treatment for HIV-positive patients


other: pharmacological study

other: laboratory biomarker analysis

drug: dasatinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina

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