NCT00301093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
13.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

March 8, 2006

Last Update Submit

October 26, 2020

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (2)

  • Disease Response

    3 years

  • Tumor immunity

    3 years

Interventions

GM-K562 cell vaccineBIOLOGICAL

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

imatinib mesylateDRUG

Participants will continue on current dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Martha Wadleigh, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

September 1, 2005

Primary Completion

May 1, 2007

Study Completion

September 10, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

US(1)