I would like to discuss a study option

[Guest guest]

Hello All,

I noticed the clinical trial information posted below on the Asian List and

I would like to have some discussion about it.

The trial is being conducted by Dr. B. Druker and it involves combining IFN

and IM. The interesting part is that depending on the response, IFN is

dropped after the first year and if a molecular remission is achieved and

held (PCRU) for two years based on bone marrow testing, IM is also dropped.

Obviously this is quite appealing to me, as I tolerated IFN so well. The

thought of a clinical trial being designed to reach an " end point " of no

further medications is incredibly exciting; particularly so because Dr. D.

is the PI.

So, below is the information on the trial. My questions are:

If you could enroll in this trial, would you?

Is there anyone among us who is on this trial?

What are any drawbacks that someone should think about with regards to this

trial?

Any general comments and your kind insight would be most helpful to me.

Warm wishes to everyone,

Cheryl-Anne

Imatinib Mesylate and Interferon Alfa in Treating Patients With

Chronic Myelogenous Leukemia

This study is currently recruiting patients.

Sponsors and Collaborators: Oregon Health and Science University

National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase

relapsing chronic myelogenous leukemia

chronic phase chronic myelogenous leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

Drug: imatinib mesylate

Drug: interferon alfa

Procedure: biological response modifier therapy

Procedure: cytokine therapy

Procedure: enzyme inhibitor therapy

Procedure: interferon therapy

Procedure: protein tyrosine kinase inhibitor therapy

Phase II

MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult

Chronic; Leukemia, Childhood

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Study of Imatinib Mesylate and Interferon

alfa in Patients With Chronic Phase Chronic Myelogenous Leukemia

Further Study Details:

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.

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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for

Study: Both

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

Philadelphia (Ph) chromosome-positive CML in chronic phase

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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier

NCT00015847

Illinois

H. Lurie Comprehensive Cancer Center at Northwestern

University, Chicago, Illinois, 60611, United States; Recruiting

Stuart Tallman, MD 312-695-4540

Oregon

Cancer Institute at Oregon Health and Science University,

Portland, Oregon, 97239, United States; Recruiting

Jay Druker, MD 503-494-5596

Study chairs or principal investigators

Jay Druker, MD, Study Chair, Oregon Health and Science

University

More Information

Clinical trial summary from the National Cancer Institute's PDQR

database

Study ID Numbers: CDR0000068443; OHSU-6263; NCI-2794; NCT00015847

Record last reviewed: March 2005

Last Updated: March 10, 2005