Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Biological: bcr-abl peptide vaccine; Biological: QS21

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004052

CDR0000067247 (Registry Identifier)

NCI-H99-0036

99-012

Details and patient eligibility

About

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.

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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