Myeloproliferative Neoplasms Clinical Trial

Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Summary

RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.

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Full Description

OBJECTIVES:

Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia.
Determine the antileukemic effects of vaccination with these peptides in these patients.

OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven chronic myelogenous leukemia

Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint
No accelerated or blastic phase
Must be in hematologic remission with peripheral WBC less than 20,000/mm^3

PATIENT CHARACTERISTICS:

Age:

Over 16

Performance status:

Karnofsky 70-100%

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics
Absolute granulocyte count greater than 1,200/mm^3
Platelet count greater than 70,000/mm^3
Hemoglobin greater than 9.0 g/dL
No active bleeding

Hepatic:

Bilirubin less than 2.0 mg/dL
Lactate dehydrogenase less than 2 times normal

Renal:

Creatinine less than 2.0 mg/dL

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

No uncontrolled active infection requiring antibiotics
No other serious illness
No immunodeficiency other than from prior bone marrow transplantation
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 6 months since prior allogeneic or autologous bone marrow transplantation
Prior vaccination with pentavalent peptide at less than study dose level allowed
At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine
Concurrent interferon allowed

Chemotherapy:

At least 2 weeks since prior low-dose subcutaneous cytarabine
At least 4 weeks since prior chemotherapy other than hydroxyurea
No concurrent chemotherapy except hydroxyurea

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery:

No concurrent surgery

Other:

Concurrent imatinib mesylate allowed
No other concurrent systemic therapy

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00004052

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 2 Locations for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00004052

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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