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Accelerated Phase Chronic Myelogenous LeukemiaPhase 1/2NCT00004918

Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

A Phase 1/2 study testing PR1 leukemia peptide vaccine, Montanide ISA 51 VG and sargramostim in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Myeloid Leukemia in Remission, run by National Cancer Institute (NCI) 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

Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
PR1 leukemia peptide vaccine, Montanide ISA 51 VG and sargramostim
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
Dec 1999to Dec 2007
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be HLA-A2 positive at one allele
  • Patients with CML in chronic phase or early accelerated phase, who are not eligible for BMT or interferon, or have failed standard therapy, or have relapsed after BMT
  • Patients with MDS (FAB subtypes RAEB, and RAEBt) or AML in second or subsequent remission, or AML with a smoldering presentation and who are not candidates for chemotherapy, and who are believed to have a life expectancy of at least 9 weeks
  • ECOG performance status < 3
  • Life expectancy is not severely limited by concomitant illness
  • Serum bilirubin < 3 mg/dl
Show all 19Show fewer
  • Serum creatinine < 2 mg/dl
  • ALT < 3 x the upper limit of normal
  • No serologic antibody against proteinase 3
  • No known history of Wegener's granulomatosis or other vasculitis
  • FEV, FVC, and DLCO > 50% of predicted, and no symptomatic pulmonary disease
  • Not pregnant; all female patients will have a serum pregnancy test, and only those that test negative will be allowed on study
  • HIV negative
  • No known allergic reaction to Montanide ISA 51 or Montanide ISA 51 VG adjuvant
  • No active uncontrolled infection
  • Patient or representative able to understand the study and consent
  • Patient is not receiving steroids, cyclosporine, or FK-506 for at least 1 month prior to study entry and during study period
  • No concomitant use of interferon or chemotherapy during study period other than hydroxyurea to control cell counts
  • Patients who relapsed within one year of completing the initial vaccination could be retreated with up to 6 additional vaccinations if they remain eligible for treatment according to the original criteria

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I/II Study of PR1 (NSC 698102) Human Leukemia Peptide Vaccine With Montanide ISA 51 (NSC 675756) or Montanide ISA 51 VG (NSC 737063) Adjuvant

Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome. This phase I/II trial is studying the side effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate both toxicity and immune response efficacy of PR1 peptide (PR1 leukemia peptide vaccine) administered subcutaneously.

SECONDARY OBJECTIVES:

  1. To evaluate possible clinical efficacy of PR1 peptide vaccine preparation with Montanide ISA 51 or Montanide ISA 51 VG adjuvant, in high-risk HLA-A2 positive patients with myeloid leukemias.

OUTLINE: This is a phase I dose-escalation study of PR1 leukemia peptide vaccine, followed by a phase II randomized study.

Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 (ISA-51) subcutaneously (SC) once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) SC with each vaccination.

Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51. Patients in each of the 3 arms receive treatment as in the phase I portion of the study.

Patients achieving a clinical response and/or clinical response to the vaccine whose disease progresses within 6-12 months after the first set of vaccinations may receive additional vaccine as before.

Patients achieving a clinical response or immune reaction to the vaccine are followed at least monthly until death or until the clinical response and/or immune reaction is lost.

PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study. A maximum of 60 patients (20 per arm) will be accrued for the phase II randomized portion of this study.

Being tested
PR1 leukemia peptide vaccine, Montanide ISA 51 VG, sargramostim, laboratory biomarker analysis
Medical subject headings
Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic-Phase, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • PR1 leukemia peptide vaccineBiological

    Also called PR1 vac, proteinase 3 PR1 peptide

    Given SC

  • Montanide ISA 51 VGDrug

    Given SC

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00004918
Study groupRoleWhat they receive
Arm I (dose level 1 PR1 leukemia peptide vaccine)ExperimentalPatients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
Receives: Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis
Arm II (dose level 2 PR1 leukemia peptide vaccine)ExperimentalPatients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
Receives: Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis
Arm III (dose level 3 PR1 leukemia peptide vaccine)ExperimentalPatients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
Receives: Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis

What is being measured

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

  1. Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0

    Measured: Up to 8 years

  2. Ability of dose

    Regression analyses will be performed.

    Measured: Up to 8 years

  3. T cell receptor (TCR) activity

    Regression analyses will be performed.

    Measured: Up to 8 years

  4. Clinical response

    Regression analyses will be performed.

    Measured: Up to 8 years

  5. Duration of first immune response (IR)

    Will be assessed using logistic regression.

    Measured: Up to 8 years

  6. Survival time

    Will be assessed using a Cox model or similar event time model

    Measured: Up to 8 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1999
  3. Primary completionDec 2007

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004918
Sponsor's protocol ID
NCI-2012-03086
Other IDs
DM 97-325
Status last verified
Jan 2013
First submitted
7 Mar 2000
Last updated
7 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PR1 leukemia peptide vaccine, Montanide ISA 51 VG and sargramostim in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Myeloid Leukemia in Remission, run by National Cancer Institute (NCI) 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?

The sponsor lists 19 inclusion and 0 exclusion criteria. 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 7 Jan 2013. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0 (time frame: Up to 8 years). The study lists 6 primary outcomes in all. 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 NCT00004918.

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 7 Jan 2013.

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