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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00301093
Collaborator
National Cancer Institute (NCI) (NIH), Beth Israel Deaconess Medical Center (Other)
3
1
180.3
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GM-K562 cell vaccine
  • Drug: imatinib mesylate
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
Sep 10, 2020

Outcome Measures

Primary Outcome Measures

  1. Safety and Toxicity [3 years]

    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

  1. Disease Response [3 years]

    To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements

  2. Tumor immunity [3 years]

    To characterize the development of tumor immunity in response to vaccination with GM-K562 cells

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Dana Farber Cancer Institute Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)
  • Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Martha Wadleigh, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martha Wadleigh, M.D., Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00301093
Other Study ID Numbers:
  • 04-126
  • R21CA115043
  • P30CA006516
  • CDR0000456445
  • NCT00215475
First Posted:
Mar 10, 2006
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020

Study Results

No Results Posted as of Oct 28, 2020