Status:
COMPLETED
Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells ...
Detailed Description
OBJECTIVES: Primary * Determine the safety, tolerability, and biological activity of everolimus when combined with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia that ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed chronic myelogenous leukemia (CML)
- In chronic phase
- Philadelphia chromosome (Ph)-positive
- No accelerated or blastic phase
- Accelerated phase CML is defined as ≥ 15% but \< 30% blasts in peripheral blood or bone marrow OR ≥ 30% blasts and promyelocytes in peripheral blood or bone marrow provided that \< 30% blasts were present OR ≥ 20% peripheral basophils OR platelet count \< 100,000/mm\^3, unrelated to therapy
- No less than 20 metaphases in the bone marrow sample
- No evidence of complete cytogenetic response to imatinib mesylate (complete cytogenetic response defined as 0% Ph-positive cells in bone marrow)
- Receiving continuous imatinib mesylate therapy for ≥ the past 9 months
- Dosage ≥ 600 mg/day for ≥ the past 3 months
- Stable dose of 600 mg/day for ≥ the past 4 weeks
- Achieved and maintained hematological response to imatinib mesylate as defined by all of the following:
- WBC \< 20,000/mm\^3
- Basophils \< 20%
- Less than 5% myelocytes and metamyelocytes in peripheral blood
- No blasts or promyelocytes in peripheral blood
- No evidence of disease-related symptoms or extramedullary disease, including enlarged spleen or liver
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Hepatic
- AST and ALT \< 1.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN (except for patients with Gilbert's disease)
- PTT \< 1.5 times ULN (except for patients on oral anticoagulation therapy)
- INR \< 1.5 times ULN (except for patients on oral anticoagulation therapy)
- Renal
- Creatinine \< 1.5 times ULN
- Cardiovascular
- No angina
- No New York Heart Association class III or IV cardiac disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- HIV negative
- No history of non-compliance with medical regimens
- No hypercholesterolemia or hypertriglyceridemia (fasting state) ≥ grade 2 (despite lipid-lowering therapy)
- No diabetes mellitus
- No thyroid dysfunction
- No neuropsychiatric disorders
- No infection
- No other severe and/or uncontrolled medical condition that would preclude study participation
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior allogeneic, syngeneic, or autologous bone marrow transplantation or stem cell transplantation for CML
- No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
- Chemotherapy
- No prior chemotherapy regimens used in transplantation
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Recovered from prior major surgery
- Other
- No prior sirolimus in combination with imatinib mesylate
- At least 4 weeks since prior investigational agents used in combination with imatinib mesylate and recovered
- No other concurrent investigational therapies
- No other concurrent anticancer agents
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093639
Start Date
August 1 2004
End Date
August 1 2006
Last Update
May 1 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001