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Imatinib Mesylate, Interferon Alfa, and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

2014-08-27 03:43:02 | BioPortfolio

Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This randomized phase II trial is studying imatinib mesylate, interferon alfa, and GM-CSF to see how well they work compared to imatinib mesylate and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.

Description

OBJECTIVES:

Primary

- Compare clinical response, in terms of 1-year progression-free survival and rate of molecular complete remission, in patients with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in chronic phase who have achieved a complete cytogenetic remission to single-agent imatinib mesylate treated with imatinib mesylate, interferon alfa, and sargramostim (GM-CSF) vs imatinib mesylate and GM-K562 cell vaccine.

Secondary

- Compare time to Ph-negativity by polymerase chain reaction after randomization.

- Compare disease-free survival and percent molecular complete remissions.

- Determine the toxicity of these treatment regimens in these patients.

OUTLINE: This is a multicenter, randomized, crossover, study. Patients are randomized to 1 of 2 treatment arms.

All patients continue to receive their standard dose of imatinib mesylate in addition to 1 of the following treatment arms:

- Arm I : Patients receive interferon alfa subcutaneously (SC) and GM-CSF SC once daily for 6 months. Patients who achieve a molecular complete remission (CR) (defined as BCR-ABL-negative disease confirmed by 2 PCR assays separated by 1 month) at the end of the 6-month period, discontinue study therapy and are monitored for disease recurrence by blood tests every 4 weeks. Patients who do not achieve a molecular CR (defined as BCR-ABL-positive disease) after completion of the initial 6 months of therapy, receive an additional 6 months of therapy as above. Patients who achieve BCR-ABL-negative disease during the additional 6 months of therapy, discontinue study therapy and are monitored for disease recurrence by blood tests every 4 weeks. Patients who remain BCR-ABL-positive by PCR after an additional 6 months of therapy, are eligible to cross over to arm II.

If at any time after stopping study therapy blood tests show disease recurrence, patients restart imatinib mesylate and are eligible to cross over to arm II. Patients are also eligible to cross over to arm II in the presence of unacceptable toxicity.

- Arm II: Patients receive GM-K562 cell vaccine intradermally once every 3 weeks for a minimum of 6 months. Patients with BCR-ABL-negative disease at the end of the 6-month period discontinue study therapy and are monitored for disease recurrence by blood tests every 4 weeks. Patients with BCR-ABL-positive disease after the completion of the initial 6 months of therapy, receive an additional 6 months of therapy as above. Patients who achieve BCR-ABL-negative disease during the additional 6 months of therapy, discontinue study therapy and are monitored every 4 weeks for disease recurrence. Patients who remain BCR-ABL-positive after the additional 6 months of therapy, are eligible to cross over to arm I.

If at any time after stopping study therapy blood tests show disease recurrence, patients restart imatinib mesylate and are eligible to cross over to arm I. Patients are also eligible to cross over to arm I in the presence of unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 1 year.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

GM-K562 cell vaccine, recombinant interferon alfa, sargramostim

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
United States
21231

Status

Recruiting

Source

Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:02-0400

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Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

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