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Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine


Phase 2
16 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine


OBJECTIVES:

- Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint
peptide vaccine in patients with chronic myelogenous leukemia.

- Determine the antileukemic effects of vaccination with these peptides in these
patients.

OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously
at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated
within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may
receive 3 additional vaccinations administered at two-month intervals.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven chronic myelogenous leukemia

- Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint

- No accelerated or blastic phase

- Must be in hematologic remission with peripheral WBC less than 20,000/mm^3

PATIENT CHARACTERISTICS:

Age:

- Over 16

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- Absolute granulocyte count greater than 1,200/mm^3

- Platelet count greater than 70,000/mm^3

- Hemoglobin greater than 9.0 g/dL

- No active bleeding

Hepatic:

- Bilirubin less than 2.0 mg/dL

- Lactate dehydrogenase less than 2 times normal

Renal:

- Creatinine less than 2.0 mg/dL

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Other:

- No uncontrolled active infection requiring antibiotics

- No other serious illness

- No immunodeficiency other than from prior bone marrow transplantation

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 6 months since prior allogeneic or autologous bone marrow transplantation

- Prior vaccination with pentavalent peptide at less than study dose level allowed

- At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte
infusion, or pentavalent vaccine

- Concurrent interferon allowed

Chemotherapy:

- At least 2 weeks since prior low-dose subcutaneous cytarabine

- At least 4 weeks since prior chemotherapy other than hydroxyurea

- No concurrent chemotherapy except hydroxyurea

Endocrine therapy:

- No concurrent corticosteroids

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- No concurrent surgery

Other:

- Concurrent imatinib mesylate allowed

- No other concurrent systemic therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kathleen Cathcart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-012

NCT ID:

NCT00004052

Start Date:

March 1999

Completion Date:

August 2005

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009