Completed

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

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What is being tested

QS21

+ bcr-abl peptide vaccine

Biological
Who is being recruted

Bone Marrow Diseases+11

+ Chronic Disease

+ Hematologic Diseases

Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004052
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveDisease AttributesLeukemiaLeukemia, Myeloid, Chronic-Phase

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Memorial Sloan-Kettering Cancer Center

New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps

University of Texas - MD Anderson Cancer Center

Houston, United States
Completed2 Study Centers