Accelerated Phase Chronic Myelogenous LeukemiaPhase 1NCT00025415

Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

A Phase 1 study testing imatinib mesylate and pharmacological study in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, AIDS-related Peripheral/Systemic Lymphoma
What is being tested?: imatinib mesylate and pharmacological study
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Aug 2001to Jan 2005
Phase: Phase 1

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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective
All tumor types are eligible, including:
Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR
Gastrointestinal stromal tumors
Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month
No unstable or untreated (non-irradiated) brain metastases

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Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
More than 3 months
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No active hemolysis
See Surgery
No evidence of biliary sepsis
Creatinine normal
Creatinine clearance at least 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Able to swallow pills
No other uncontrolled concurrent illness that would preclude study participation
No ongoing or active infection
No uncontrolled diarrhea
No psychiatric illness or social situation that would preclude study compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 6 months after study completion
At least 24 hours since prior colony-stimulating factors
No concurrent colony-stimulating factors
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
See Disease Characteristics
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
See Disease Characteristics
At least 10 days since prior placement of shunt for treatment of biliary obstruction
At least 14 days since prior major surgery
No prior solid organ transplantation
No other concurrent investigational agents
No concurrent therapeutic doses of warfarin for anticoagulation
No other concurrent investigational or commercial agents or therapies for treatment of this disease
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent acetaminophen of more than 4,000 mg/day

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction

Read the detailed description

PRIMARY OBJECTIVES:

Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction.

II. Determine the effects of hepatic dysfunction on the pharmacodynamics and pharmacokinetics of this drug in these patients.

III. Determine the non-dose-limiting toxic effects of this drug in these patients.

IV. Determine the response rate of these patients treated with this drug. V. Correlate the Childs-Pugh classification of hepatic dysfunction with observed toxic effects, pharmacodynamics, and pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver dysfunction (normal vs mild vs moderate vs severe).

Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate 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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
Being tested: imatinib mesylate, pharmacological study
Medical subject headings: Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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
pharmacological studyOther
Also called pharmacological studies
Correlative studies

Study groups in NCT00025415
Study group	Role	What they receive
Treatment (imatinib mesylate)	Experimental	Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate 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 Receives: Drug: imatinib mesylate; Other: pharmacological study

What is being measured

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

MTD defined based on the toxicities observed during the first cycle of treatment
Measured: 4 weeks
Toxicity evaluation graded according to the NCI common toxicity criteria and relationship to the study drug
Results will be tabulated by liver dysfunction group.
Measured: Up to 4 years

Secondary outcomes (3)

Pharmacokinetic data
Will be analyzed with ADAPT II, and results will be summarized separately for the four study groups. Additionally, results for pharmacokinetic parameters will be related to the measured level of liver dysfunction in exploratory analyses.
Measured: Day 1, 2, 3, 4, 15, 16
Responses
Will be tabulated by liver dysfunction group, and by dose if appropriate.
Measured: Up to 4 years
Child-Pugh Classification
Will be correlated to the toxicities, pharmacokinetic and pharmacodynamic data seen with STI571.
Measured: Baseline

Timeline

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

Aug 2001Jan 2005

First posted27 Jan 2003 (estimated)
Study startAug 2001
Primary completionJan 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00025415
Sponsor's protocol ID: NCI-2012-02418
Other IDs: 01-028, U01CA099168, U01CA062505, U01CA062491, U01CA062502, U01CA062487, CDR0000068959
Status last verified: Feb 2013
First submitted: 11 Oct 2001
Last updated: 7 Feb 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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