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

Alternate Title

Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia in Remission

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed over 18 NCI MSKCC-95029A3 NCI-H95-0683

Objectives

I.  Evaluate, in patients with chronic myelogenous leukemia (CML), the safety 
and toxicity of vaccination with tumor-specific CML breakpoint peptides plus 
the immunologic adjuvant QS21.

II.  Evaluate the immunogenicity of CML breakpoint peptides in these patients.

III.  Evaluate antileukemic effects of vaccination with CML breakpoint 
peptides.

Entry Criteria

Disease Characteristics:

Chronic myelogenous leukemia (CML) with either a (9;22) translocation or
bcr/abl transcript and a b3a2 breakpoint
  Pathologic review and cytogenetics performed or reviewed at Memorial
  Hospital

Partial or complete hematologic remission required (WBC less than 20,000)

No accelerated or blastic phase CML

Following determination of the maximum tolerated dose, HLA-A3, -A11, or -B8
required

Prior/Concurrent Therapy:

Biologic therapy:
  Concurrent interferon allowed
  At least 4 weeks since other immunotherapy

Chemotherapy:
  At least 4 weeks since chemotherapy
  Concurrent hydroxyurea permitted

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Other:
  At least 6 months since allogeneic or autologous bone marrow transplant

Patient Characteristics:

Age:
  Over 18

Performance status:
  Karnofsky 70%-100%

Life expectancy:
  Greater than 3 months

Hematopoietic:
  Absolute granulocyte count greater than 1,200/mm3
  Platelet count greater than 80,000/mm3
  Hemoglobin greater than 9 g/dL

Hepatic:
  Bilirubin less than 2 mg/dL
  LDH less than 300 U/L

Renal:
  Creatinine less than 2 mg/dL

Cardiovascular:
  No clinically significant heart disease (NYHA class III/IV)

Other:
  No active bleeding
  No active infection requiring antibiotics
  No known immunodeficiency (other than related to bone marrow transplant)
  No serious intercurrent illness
  No pregnant or nursing women
  No requirement for corticosteroids

Expected Enrollment

Up to 38 patients will be entered over 2 years.  If there is a greater than 
30% incidence of DLT at the MTD, accrual will stop.

Outline

Tumor-Specific Vaccine Therapy.  Vaccination with CML breakpoint peptides 
(equal mixture of 4 class I and 1 class II peptides); plus the immunologic 
adjuvant QS21.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

David Scheinberg, MD, PhD, Protocol chair		Ph: 646-888-2190; 800-525-2225 Email: d-scheinberg@ski.mskcc.org