Myeloproliferative Neoplasms Clinical Trial

Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Summary

RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia.

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Full Description

OBJECTIVES:

Determine the maximum tolerated dose of interferon alfa administered with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia. (Phase I closed to accrual as of 7/9/03.)
Determine the safety and tolerability of this regimen in this patient population.
Determine the complete, major, and minor cytogenetic response rates and complete hematologic response rate in patients after 6 and 12 months of treatment with this regimen.
Determine the molecular response (reverse transcriptase-polymerase chain reaction for bcr-abl) rate in patients who have a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Phase I (closed to accrual as of 7/9/03): Patients receive oral imatinib mesylate once daily beginning on day 1 and interferon alfa (IFN-A) subcutaneously once daily or 3 times weekly beginning on day 14. Courses repeat every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of 1 year of therapy, patients may receive additional therapy, provided that the patient is benefiting from imatinib mesylate. IFN-A is discontinued in patients who achieve a molecular remission that is confirmed on 2 successive bone marrow samples. Imatinib mesylate is discontinued in patients who achieve and maintain a molecular remission for 2 years.

Sequential dose escalation of IFN-A is followed by sequential dose escalation of imatinib mesylate. Cohorts of 3-6 patients receive escalating doses of IFN-A and then imatinib mesylate until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive imatinib mesylate and IFN-A as in phase I at the established MTD.

Patients are followed for 30 days.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for the phase I portion of this study. (Phase I closed to accrual as of 7/9/03.) A total of 40 patients will be accrued for the phase II portion of the study within 3-4 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Cytogenetically confirmed chronic myelogenous leukemia (CML)

Less than 15% blasts in peripheral blood or bone marrow
Less than 30% blasts and promyelocytes in peripheral blood or bone marrow
Less than 20% basophils in blood or bone marrow
Platelet count at least 100,000/mm^3
No leukemia beyond bone marrow, blood, liver, or spleen
No chloroma

Phase I (closed to accrual as of 7/9/03):

Philadelphia (Ph) chromosome-positive CML in chronic phase

Phase II:

Newly diagnosed Ph chromosome-positive CML in chronic phase
Initial diagnosis within 6 months of study
No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride

Phase I (closed to accrual as of 7/9/03) and II:

No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 2 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of effective barrier contraception during and for at least 3 months after study participation
No other serious uncontrolled medical condition
No autoimmune disease
No prior noncompliance to medical regimens or potential unreliability
No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I [closed to accrual as of 7/9/03])

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
No prior bone marrow or peripheral blood stem cell transplantation
At least 2 weeks since prior interferon alfa (phase I [closed to accrual as of 7/9/03])

Chemotherapy:

See Disease Characteristics
At least 6 weeks since prior busulfan (phase I [closed to accrual as of 7/9/03] )
At least 2 weeks since prior cytarabine (phase I [closed to accrual as of 7/9/03])
No concurrent chemotherapy
Concurrent hydroxyurea allowed during the first 3 months of study

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I [closed to accrual as of 7/9/03])
No concurrent grapefruit juice
Concurrent anagrelide hydrochloride allowed during the first 3 months of study

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00015847

Recruitment Status:

Terminated

Sponsor:

OHSU Knight Cancer Institute

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There are 2 Locations for this study

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00015847

Recruitment Status:

Terminated

Sponsor:


OHSU Knight Cancer Institute

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