search
Back to results

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GM-K562 cell vaccine
imatinib mesylate
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia Chronic phase disease Philadelphia chromosome positive disease Disease in first complete hematologic response, defined by all of the following: Complete normalization of peripheral blood counts with WBC < 10,000/mm^3 Platelet count < 450,000/mm^3 No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood Persistent molecular evidence of disease Detectable BCR-ABL transcript by quantitative polymerase chain reaction Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No known HIV ALT or AST ≤ 3 times upper limit of normal Oxygen saturation ≥ 93% at room air No history of recent acute myocardial infarction No history of unstable angina No pulmonary decomposition requiring hospitalization within the past 3 months No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior allogeneic stem cell transplantation At least 2 months since other prior experimental therapy At least 6 months since prior participation in another vaccine study No concurrent systemic immunosuppressive medication

Sites / Locations

  • Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Safety and Toxicity
To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.

Secondary Outcome Measures

Disease Response
To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
Tumor immunity
To characterize the development of tumor immunity in response to vaccination with GM-K562 cells

Full Information

First Posted
March 8, 2006
Last Updated
October 26, 2020
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00301093
Brief Title
Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Official Title
Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.
Detailed Description
OBJECTIVES: Primary Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response. Determine the safety and toxic effects of GM-K562 cell vaccination in these patients. Secondary Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen. Determine the development of tumor immunity in patients treated with this regimen. OUTLINE: This is a dose-escalation study of GM-K562. Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity. Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically for 20 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
GM-K562 cell vaccine
Intervention Description
Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
Participants will continue on current dose
Primary Outcome Measure Information:
Title
Safety and Toxicity
Description
To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease Response
Description
To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
Time Frame
3 years
Title
Tumor immunity
Description
To characterize the development of tumor immunity in response to vaccination with GM-K562 cells
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia Chronic phase disease Philadelphia chromosome positive disease Disease in first complete hematologic response, defined by all of the following: Complete normalization of peripheral blood counts with WBC < 10,000/mm^3 Platelet count < 450,000/mm^3 No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood Persistent molecular evidence of disease Detectable BCR-ABL transcript by quantitative polymerase chain reaction Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No known HIV ALT or AST ≤ 3 times upper limit of normal Oxygen saturation ≥ 93% at room air No history of recent acute myocardial infarction No history of unstable angina No pulmonary decomposition requiring hospitalization within the past 3 months No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior allogeneic stem cell transplantation At least 2 months since other prior experimental therapy At least 6 months since prior participation in another vaccine study No concurrent systemic immunosuppressive medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Wadleigh, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

We'll reach out to this number within 24 hrs