RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Vaccines made from a person's white blood cells, such as AG-858, may make the body build an immune response to kill cancer cells. Combining AG-858 with imatinib mesylate may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining AG-858 with imatinib mesylate in treating patients who are currently receiving imatinib mesylate for chronic phase chronic myelogenous leukemia.

Condition	Treatment or Intervention	Phase
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia	Drug: AG-858  Drug: imatinib mesylate  Procedure: biological response modifier therapy  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy  Procedure: tumor cell derivative vaccine  Procedure: vaccine therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine complete cytogenetic response rates in patients with chronic phase chronic myelogenous leukemia who are cytogenetically positive after prior treatment with imatinib mesylate and are now treated with AG-858 while continuing imatinib mesylate.

Secondary

• Determine the substantial molecular response rates in patients treated with this regimen.
• Determine the frequency and severity of adverse events in patients treated with this regimen.
• Determine the feasibility of AG-858 production in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to cytogenetic status.

Patients continue to receive oral imatinib mesylate on their pre-study schedule. Patients undergo leukapheresis for the production of AG-858. Patients receive AG-858 intradermally once weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 and 16 weeks.

PROJECTED ACCRUAL: A total of 60-120 patients (20-40 per stratum) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia (CML)
• In first chronic phase
• In complete hematologic response
• Currently receiving imatinib mesylate for CML in 1 of the following settings:
• As first therapy for CML
• After prior therapy with interferon alfa, cytarabine, busulfan, hydroxyurea, or any combination thereof
• Cytogenetic status meets criteria for 1 of the following:
• Less than a complete cytogenetic response (CCR) after receiving imatinib mesylate* for at least 1 year
• Must have received a stable dose of imatinib mesylate for the last 6 months
• Stable cytogenetic status without CCR (neither response nor progression) by 3 consecutive determinations over 6 months while receiving imatinib mesylate*
• Cytogenetic progression by 2 determinations at least 1 month apart while receiving imatinib mesylate* NOTE: *At least 400 mg/day
• Not a candidate for curative bone marrow transplantation

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

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

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study participation
• No autoimmune disorder
• No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• No severe active infection
• No other serious medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• No prior allogeneic bone marrow transplantation
• No concurrent routine growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• See Disease Characteristics
• No other prior therapy for CML
• No other concurrent anticancer therapies
• No concurrent cyclosporine
• No concurrent immunosuppressants

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095,  United States; Recruiting

Study chairs or principal investigators

Ronald Paquette, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000334026; UCLA-0304072; ANTIGENICS-C-300-01
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070395
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08