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Accelerated Phase Chronic Myelogenous LeukemiaPhase 1NCT00101088

Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

A Phase 1 study testing imatinib mesylate, temsirolimus and laboratory biomarker analysis in people with Accelerated Phase Chronic Myelogenous Leukemia and Blastic Phase Chronic Myelogenous Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
imatinib mesylate, temsirolimus and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Apr 2005to Jun 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 75Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia

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

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
imatinib mesylate, temsirolimus, laboratory biomarker analysis
Medical subject headings
Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given orally

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00101088
Study groupRoleWhat they receive
Treatment (imatinib mesylate, temsirolimus)ExperimentalPatients 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
Receives: Drug: imatinib mesylate; Drug: temsirolimus; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unacceptable toxicity graded according to the NCI CTCAE version 3.0

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Disease progression

    Measured: Up to 5 years

  2. Duration of response

    Presented using descriptive statistics.

    Measured: Up to 5 years

  3. Survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101088
Sponsor's protocol ID
NCI-2009-00073
Other IDs
UCI-04-04, R21CA112936
Status last verified
Jan 2013
First submitted
7 Jan 2005
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing imatinib mesylate, temsirolimus and laboratory biomarker analysis in people with Accelerated Phase Chronic Myelogenous Leukemia and Blastic Phase Chronic Myelogenous Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 75 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unacceptable toxicity graded according to the NCI CTCAE version 3.0 (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.

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