Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00428077
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 4
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: bcr-abl peptide vaccine; Genetic: reverse transcriptase-polymerase chain reaction	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2005
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

1. 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. [Every 3 months for the duration of 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.

2. Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts [12-24 Months]

3. Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions [12-24 Months]

4. Immunologic Response Over 1 Year [12 months]

5. Correlation of Response With Specific HLA Types [12-24 Months]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239-3098

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Study Chair: Michael Deininger, MD, PhD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT00428077
• Other Study ID Numbers: CDR0000526322; OHSU-HEM-05053-L; OHSU-1358
• First Posted: Jan 29, 2007
• Last Update Posted: Sep 2, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by OHSU Knight Cancer Institute: Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Study Results

Participant Flow

Recruitment Details	Recruited from patient database in medical clinic.

Arm/Group Title	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
Arm/Group Description	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.
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 75%
>=65 years	1 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.75 (3.59)
Sex: Female, Male (Count of Participants)
Female	1 25%
Male	3 75%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.
Time Frame	Every 3 months for the duration of the 1-year treatment period. .

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
Arm/Group Description	Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
Measure Participants	4
Number [Participants]	4 100%

2. Primary Outcome

Title	Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
Time Frame	12-24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
Time Frame	12-24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Immunologic Response Over 1 Year
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

Title	Correlation of Response With Specific HLA Types
Time Frame	12-24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.
Time Frame	Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events were measured during entire 12 month period subjects received study drug.
Arm/Group Title	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
Arm/Group Description	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.
All Cause Mortality
	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
	Affected / at Risk (%)	# Events
Total	1/4 (25%)
Gastrointestinal disorders
Acute Viral Gastroenteritis	1/4 (25%)	1
Other (Not Including Serious) Adverse Events
	Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)
	Affected / at Risk (%)	# Events
Total	4/4 (100%)
Eye disorders
Cataracts	1/4 (25%)	1
General disorders
Fatigue	3/4 (75%)
Skin and subcutaneous tissue disorders
Injection site induration	4/4 (100%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.