Clinical trial NCT00004052: Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Official title: Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathleen Cathcart, MD
role: STUDY_CHAIR
References: