Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

NCT00004052 | Completed Phase 2

• 3 other identifiers: 99-012CDR0000067247NCI-H99-0036
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia

Interventions

QS21 BIOLOGICAL

bcr-abl peptide vaccine BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase

Interventions

saponin QA-21V1

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen Cathcart, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: May 8, 2003
• Study Start: March 1, 1999
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (2)