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LeukemiaPhase 1NCT00301093

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

A Phase 1 study testing GM-K562 cell vaccine and imatinib mesylate in people with Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
GM-K562 cell vaccine and imatinib mesylate
Type of treatment
Vaccines
How many people
3 participants
Where
1 siteUnited States
Study dates
Sep 2005to 10 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate

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.

Read the 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.

Conditions
Leukemia
Being tested
GM-K562 cell vaccine, imatinib mesylate
Keywords
chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (2)

  1. Disease Response

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

    Measured: 3 years

  2. Tumor immunity

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2007
  4. Study completion10 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301093
Sponsor's protocol ID
04-126
Other IDs
R21CA115043, P30CA006516, CDR0000456445
Status last verified
Oct 2020
First submitted
8 Mar 2006
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GM-K562 cell vaccine and imatinib mesylate in people with Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Toxicity (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.

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