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
I. To evaluate both toxicity and immune response efficacy of PR1 peptide (PR1 leukemia
peptide vaccine) administered subcutaneously.
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0
Up to 8 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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