Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	Over 18	NCI	MDA-DM-97325 NCI-T98-0017, NCT00004918, T98-0017

Objectives

1. Determine the toxicity and immunological activity of PR1 leukemia peptide vaccine administered with Montanide ISA-51 in patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndromes.
2. Evaluate possible clinical efficacy of this vaccine in high-risk HLA-A2-positive patients with myeloid leukemias.

Entry Criteria

Disease Characteristics:

• Diagnosis of chronic myeloid leukemia in chronic phase or early accelerated phase
  • Ineligible for bone marrow transplantation (BMT) or interferon

    OR

  • Failed standard therapy

    OR

  • Relapsed after BMT

  OR




• Diagnosis of 1 of the following diseases and not a candidate for chemotherapy:
  • Myelodysplastic syndromes in second or subsequent remission
    • Refractory anemia with excess blasts (RAEB)

      OR

    • RAEB in transformation
  • Acute myeloid leukemia (AML) in second or subsequent remission
  • AML with a smoldering presentation



• HLA-A2 positive at one allele

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No concurrent interferon

Chemotherapy:

• See Disease Characteristics
• No concurrent chemotherapy except hydroxyurea to control cell counts

Endocrine therapy:

• At least 1 month since prior steroids
• No concurrent steroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• At least 1 month since prior cyclosporine or tacrolimus
• No concurrent cyclosporine or tacrolimus

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 9 weeks

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 3 mg/dL
• ALT less than 3 times upper limit of normal

Renal:

• Creatinine less than 2 mg/dL

Pulmonary:

• FEV, FVC, and DLCO greater than 50% of predicted
• No symptomatic pulmonary disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent illness that severely limits life expectancy
• No known history of Wegener's granulomatosis or other vasculitis
• No known allergy to Montanide ISA-51
• No active uncontrolled infection
• No serologic antibody against proteinase 3
• HIV negative

Expected Enrollment

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.

Outcomes

Immune response at 3 weeks after last vaccine
Clinical response at 3 weeks after last vaccine

Event-free survival as measured by Kaplan-Meier at 1 year
Overall survival as measure by Kaplan-Meier at 1 year

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Muzaffar Qazilbash, MD, Protocol chair		Ph: 713-792-4326; 800-392-1611
Richard Champlin, MD, Protocol co-chair		Ph: 713-792-3618; 800-392-1611 Email: rchampli@mdanderson.org

Registry Information
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
Trial Start Date		1999-12-15
Trial Completion Date		2007-12-19
Registered in ClinicalTrials.gov		NCT00004918
Date Submitted to PDQ		2000-01-13
Information Last Verified		2008-10-20
NCI Grant/Contract Number		CA16672, CA81247

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