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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-HEM-05053-L | |||
| OHSU-1358 |
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Withdrawn because there were no dramatic changes in the main endpoint, as well as low enrollment numbers. The data are not interpretable in terms of efficacy.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML)
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Deininger, MD, PhD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239-3098 | United States |
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Recruited from patient database in medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) | Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) | Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol. | Posted | Number | Participants | Every 3 months for the duration of the 1-year treatment period. . |
|
Adverse events were measured during entire 12 month period subjects received study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) | Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Viral Gastroenteritis | Gastrointestinal disorders | In one patient a grade 3 GI AE (acute gastroenteritis) occurred and led to hospitalization. This event was felt to be unrelated to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | Skin and subcutaneous tissue disorders | All patients developed grade 1-2 injections site indurations, which slowly resolved over several months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Deininger, MD, PhD | University of Utah Huntsman Cancer Institute | 801-585-3229 | michael.deininger@hci.utah.edu |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts | Not Posted | 12-24 Months |
| Primary | Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions | Not Posted | 12-24 Months |
| Primary | Immunologic Response Over 1 Year | Not Posted | 12 months |
| Primary | Correlation of Response With Specific HLA Types | Not Posted | 12-24 Months |
| Secondary | Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment. | Not Posted | Number | participants | Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years. |
| 1 |
| 4 |
| 4 |
| 4 |
|
|
| Fatigue | General disorders | Patients experienced grade 1-2 fatigue in association with the injection of GM-CSF. This is an established side effect of the agent. |
|
| Cataracts | Eye disorders | One patient was diagnosed with grade 2 cataracts while on study. Given that this is common in the patient's age group, it is unlikely to be related to study medication. |
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| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |