Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Stopped early · Phase 1

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, Relapsing Chronic Myelogenous Leukemia

In brief

This phase I trial is studying the side effects and best dose of temsirolimus when given with imatinib mesylate in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus with imatinib mesylate may kill more cancer cells

Key facts

Study ID

NCT00101088

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2005-04-01

Last updated by the study team

2013-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed chronic myelogenous leukemia (CML)
• Philadelphia chromosome-positive OR Bcr-Abl-positive disease, meeting 1 of the following criteria:
• Accelerated phase, defined by at least 1 of the following:
• 10-19% blasts in the peripheral blood or bone marrow
• At least 20% basophils in peripheral blood or bone marrow
• Platelet count < 100,000/mm\^3 (unrelated to therapy)
• Platelet count > 1,000,000/mm\^3 (unresponsive to therapy)
• Increasing splenomegaly AND increasing WBC count (unresponsive to therapy)
• Clonal evolution
• Blast phase, defined by 1 of the following:
• At least 20% blasts in peripheral blood or bone marrow
• Extramedullary disease
• Chronic phase, defined by all of the following:
• Less than 10% blasts in peripheral blood or bone marrow
• Less than 20% basophils in peripheral blood or bone marrow
• Platelet count > 100,000/mm\^3
• Absence of clonal evolution
• May have received and/or failed prior imatinib mesylate therapy
• Patients not previously treated with imatinib mesylate receive oral imatinib mesylate once daily 14 days before beginning study drug
• Must be able to tolerate 600 mg per day of imatinib mesylate before starting CCI-779
• Patients with chronic phase disease must have failed prior imatinib mesylate at a dose ≥ 600 mg/day, as defined by 1 of the following:
• Must not have achieved or must have lost hematologic response within 3 months after the start of imatinib mesylate
• Must not have achieved or must have lost cytogenetic response after 6 months of treatment with imatinib mesylate
• Must not have achieved or must have lost major cytogenetic response after 12 months of treatment with imatinib mesylate
• Must have lost complete cytogenetic response

Where it is running

• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States

Full record on ClinicalTrials.gov

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