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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Martha Wadleigh, M.D., Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00301093
First received: March 8, 2006
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: GM-K562 cell vaccine
Drug: imatinib mesylate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Safety and Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements

  • Tumor immunity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To characterize the development of tumor immunity in response to vaccination with GM-K562 cells


Estimated Enrollment: 30
Study Start Date: September 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: GM-K562 cell vaccine
    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
    Drug: imatinib mesylate
    Participants will continue on current dose
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301093

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Martha Wadleigh, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Martha Wadleigh, M.D., Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00301093     History of Changes
Obsolete Identifiers: NCT00215475
Other Study ID Numbers: 04-126, R21CA115043, P30CA006516, CDR0000456445
Study First Received: March 8, 2006
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014