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

NCT00316953 | Completed Phase 1

• 4 other identifiers: NCI-2012-01824ADVL0516U10CA97452CDR0000467233
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose defined as the maximum dose at which fewer than 1/3 patients experience dose-limiting toxicities (DLT) graded according to CTCAE

  28 days

• Time to disease progression

  Will be estimated separately for patients on the solid tumor and on the refractory Ph+ leukemia strata with the Kaplan Meier method.

  Interval from enrollment to disease progression, death, occurrence of a second malignant neoplasm or last patient contact, assessed up to 1 month

Study Arms (2)

Stratum 1 (solid tumors)

EXPERIMENTAL

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.

Drug: dasatinib; Other: pharmacological study; Other: laboratory biomarker analysis

Stratum 2 (leukemia)

EXPERIMENTAL

Patients receive dasatinib as in stratum 1. 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.

Drug: dasatinib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

dasatinib DRUG

Given orally

Also known as: BMS-354825, Sprycel

Stratum 1 (solid tumors); Stratum 2 (leukemia)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Stratum 1 (solid tumors); Stratum 2 (leukemia)

laboratory biomarker analysis OTHER

Correlative studies

Stratum 1 (solid tumors); Stratum 2 (leukemia)

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Richard Aplenc

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: March 1, 2006
• Primary Completion: September 1, 2009
• Last Updated: February 5, 2013

Record last verified: 2013-01

Locations

US (1)