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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


Phase 1/Phase 2
19 Years
N/A
Not Enrolling
Both
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia in Remission, Chronic Phase Chronic Myelogenous Leukemia, Previously Treated Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia

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Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.


Inclusion Criteria:



- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 8 years

Safety Issue:

Yes

Principal Investigator

Muzaffar Qazilbash

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03086

NCT ID:

NCT00004918

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Accelerated Phase Chronic Myelogenous Leukemia
  • Adult Acute Myeloid Leukemia in Remission
  • Chronic Phase Chronic Myelogenous Leukemia
  • Previously Treated Myelodysplastic Syndromes
  • Refractory Anemia With Excess Blasts
  • Refractory Anemia With Excess Blasts in Transformation
  • Relapsing Chronic Myelogenous Leukemia
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Myelodysplastic Syndromes
  • Preleukemia
  • Anemia, Aplastic

Name

Location
M D Anderson Cancer Center Houston, Texas  77030