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

Completed · Phase 1

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Meningeal Chronic Myelogenous Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Relapsing Chronic Myelogenous Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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

Key facts

Study ID

NCT00316953

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2006-03-01

Last updated by the study team

2013-02-05

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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