Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004052
• Other study ID #: 99-012
• Secondary ID: CDR0000067247NCI
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: June 24, 2013
• Start date: March 1999
• Est. completion date: August 2005

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Biological:
• QS21

• bcr-abl peptide vaccine

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,