Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

NCT00428077 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000526322OHSU-HEM-05053-LOHSU-1358
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with chronic phase chronic myelogenous leukemia.

Conditions

Leukemia

Keywords

Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (5)

• Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.

  One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.

  Every 3 months for the duration of the 1-year treatment period. .

• Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts

  12-24 Months

• Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions

  12-24 Months

• Immunologic Response Over 1 Year

  12 months

• Correlation of Response With Specific HLA Types

  12-24 Months

Secondary Outcomes (1)

• Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.

  Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.

Interventions

bcr-abl peptide vaccine BIOLOGICAL

Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.

reverse transcriptase-polymerase chain reaction GENETIC

A "baseline" reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a "baseline" circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML) * In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart * Minimal residual disease * Detectable BCR-ABL transcript levels obtained \< 6 months apart AND ≤ 0.5-log lower than the lowest value obtained within the past 6 months PATIENT CHARACTERISTICS: * Karnofsky performance status 80-100% * Bilirubin \< 2 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * ALT and AST \< 2.5 times ULN PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * No major surgery within the past 4 weeks * No prior chemotherapy * No prior immunosuppressive therapy * No prior corticosteroids * No prior stem cell transplantation * No radiotherapy within the past 4 weeks * No other concurrent investigational agents

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Results Point of Contact

• Title: Michael Deininger, MD, PhD
• Organization: University of Utah Huntsman Cancer Institute

michael.deininger@hci.utah.edu

801-585-3229

Study Officials

• Michael Deininger, MD, PhD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: October 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 2, 2011
• Results First Posted: August 31, 2011

Record last verified: 2011-08

Locations

US (1)