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.

Condition	Treatment or Intervention	Phase
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia	Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Vaccine: non-tumor cell derivative vaccine  Procedure: vaccine therapy  Drug: bcr-abl peptide vaccine  Drug: QS21	Phase II

Further Study Details: 

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

PROTOCOL 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY 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/mm3

--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

--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/mm3
• Platelet count greater than 70,000/mm3
• 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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Kathleen Cathcart,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067247; MSKCC-99012; NCI-H99-0036
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004052
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08