Clinical trial NCT00428077: Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Keywords: Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-01-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Every 3 months for the duration of the 1-year treatment period. .
measure: Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
timeFrame: 12-24 Months
measure: Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
timeFrame: 12-24 Months
measure: Immunologic Response Over 1 Year
timeFrame: 12 months
measure: Correlation of Response With Specific HLA Types
timeFrame: 12-24 Months
Secondary outcomes:
measure: Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.
timeFrame: Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Michael Deininger, MD, PhD
role: STUDY_CHAIR
References: