- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00101088
Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
I. Determine the safety and tolerability of temsirolimus when administered with imatinib mesylate in patients with chronic myelogenous leukemia.
II. Determine potential dose-limiting toxic effects of this regimen in these patients.
III. Determine, preliminarily, hematologic and cytogenetic response rates in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of temsirolimus.
Patients receive temsirolimus intravenously (IV) over 30 minutes once on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients receive 2 additional courses beyond maximal response. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
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Orange, California, Förenta staterna, 92868
- University of California Medical Center At Irvine-Orange Campus
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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
- Bone marrow aspirate and biopsy with cytogenetics and fluorescent in situ hybridization confirming t(9;22) completed within the past 28 days
- Performance status - SWOG 0-2
- More than 3 months
- See Disease Characteristics
- Bilirubin normal
- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if suspected liver involvement with leukemia)
- Creatinine normal
- Creatinine clearance > 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Ejection fraction ≥ 50% by echocardiogram or MUGA scan for patients with known positive cardiac history (e.g., heart failure, coronary artery disease, cardiomegaly on prior chest x-ray, or valvular heart disease)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Fasting cholesterol ≤ 350 mg/dL
- Fasting triglycerides ≤ 400 mg/dL
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to temsirolimus or imatinib mesylate
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other active malignancy except nonmelanoma skin cancer
- No other uncontrolled illness
- At least 48 hours since prior interferon alfa for CML
- At least 6 weeks since prior stem cell transplantation
- No concurrent biologic agents
- No concurrent prophylactic colony-stimulating factors
- At least 24 hours since prior hydroxyurea for CML
- At least 7 days since prior mercaptopurine or vinca alkaloids for CML
- At least 7 days since prior low-dose cytarabine (< 30 mg/m^2 every 12-24 hours) for CML
- At least 14 days since prior homoharringtonine for CML
- At least 14 days since prior moderate-dose cytarabine (100-200 mg/m^2 for 5-7 days) for CML
- At least 21 days since prior anthracyclines, mitoxantrone, cyclophosphamide, etoposide, or methotrexate for CML
- At least 28 days since prior high-dose cytarabine (1-3 g/m^2 every 12-24 hours for 6-12 doses) for CML
- At least 6 weeks since prior busulfan for CML
- No concurrent hydroxyurea
- No other concurrent chemotherapy
- At least 7 days since prior steroids for CML
- No prior organ transplantation
- More than 2 weeks since prior major surgery (e.g., thoracotomy or intra-abdominal surgery)
- Recovered from all prior therapy
- Prior experimental therapy allowed provided completion of treatment corresponds to a duration > 5 half-lives of the experimental drug or any known active metabolite before study
- No concurrent cyclosporine
- No concurrent anagrelide
- No concurrent oral anticoagulants, including warfarin
- No concurrent CYP3A4 inducers or inhibitors
- No concurrent tacrolimus
- No concurrent plasmapheresis
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer therapies
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment (imatinib mesylate, temsirolimus)
Patients receive temsirolimus IV over 30 minutes once on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-28.
Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
|
Korrelativa studier
Ges oralt
Andra namn:
Givet IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Unacceptable toxicity graded according to the NCI CTCAE version 3.0
Tidsram: Up to 5 years
|
Up to 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sjukdomsprogression
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
Överlevnad
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
Duration of response
Tidsram: Up to 5 years
|
Presented using descriptive statistics.
|
Up to 5 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tiong Ong, University of California Medical Center At Irvine-Orange Campus
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Myeloproliferativa störningar
- Neoplastiska processer
- Celltransformation, neoplastisk
- Carcinogenes
- Leukemi
- Leukemi, myeloid
- Leukemi, Myelogen, Kronisk, BCR-ABL positiv
- Leukemi, Myeloid, Kronisk fas
- Blast Crisis
- Leukemi, Myeloid, Accelererad Fas
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Proteinkinashämmare
- Antibiotika, antineoplastiska
- Antifungala medel
- Imatinib Mesylate
- Sirolimus
Andra studie-ID-nummer
- NCI-2009-00073
- UCI-04-04
- R21CA112936 (U.S.S. NIH-anslag/kontrakt)
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