Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

A Multi-Center Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00428077
• Other study ID #: CDR0000526322
• Secondary ID: OHSU-HEM-05053-L
• Status: Terminated
• Phase: Phase 2
• First received: January 25, 2007
• Last updated: August 31, 2011
• Start date: October 2005
• Est. completion date: April 2009

Study information

• Verified date: August 2011
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the antileukemic effects of tumor-specific Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) junction specific peptide vaccine, as measured by a decrease in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR), that persist for at least 3 months, in patients with chronic phase chronic myelogenous leukemia.

• Determine the percentage of patients treated with this vaccine who become RT-PCR-negative for BCR-ABL transcripts.

• Compare response in patients with B3A2 junctions vs B2A2 junctions when treated with this vaccine.

• Determine the immunologic response over 1 year in patients treated with this vaccine.

• Correlate response with specific HLA types in these patients.

• Determine the safety of this vaccine in these patients.

OUTLINE: This is a pilot, multicenter study.

Patients receive BCR-ABL junction-specific peptide vaccine subcutaneously in weeks 2, 4, 6, 8, and 11 and then once monthly for 10 months.

BCR-ABL transcript levels are assessed by quantitative reverse-transcriptase polymerase chain reaction at baseline, weeks 2, 4, and 6, every 3 months during treatment, and then 2 weeks after completion of study treatment.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• bcr-abl peptide vaccine
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.

Genetic:
• reverse transcriptase-polymerase chain reaction
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.

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. .	No
Primary	Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts		12-24 Months	No
Primary	Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions		12-24 Months	No
Primary	Immunologic Response Over 1 Year		12 months	No
Primary	Correlation of Response With Specific HLA Types		12-24 Months	No
Secondary	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.	Yes