Trial Information

Summary: Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission

A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study

Patient Inclusion Criteria =Diagnosis of acute myeloid leukemia (AML), defined by the presence of > 20% blasts in marrow or blood, including the following subtypes:

• De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents
• Secondary AML, defined as the following:
• AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure
• History of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ¡Ý 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia
• In first complete remission (CR) (patients ¡Ý 55 years of age) OR second CR (patients ¡Ý 18 years of age) within the past month

FAB stages M0-M2 and M4-M7 allowed if in first CR

No acute promyelocytic leukemia in first CR
FAB stages M0-M7 allowed if in second CR
Marrow blast count < 5% (¡Ü 200 nucleated cell count)

No blasts in blood
HLA-A2 positive at 1 allele
No extramedullary disease
No Auer rods
No active meningeal or CNS leukemia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy must not be severely limited by other diseases
• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 100,000/mm^3
• Bilirubin < 2 mg/mL
• ALT < 2 times upper limit of normal
• Creatinine ¡Ü 1.6 mg/mL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Antineutrophil cytoplasmic antibody negative
• No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient
• No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast
• No known allergy to incomplete Freund's adjuvant
• No hypercalcemia
• No progressive viral or bacterial infection
• Must be afebrile for 7 days without antibiotics
• No symptomatic cardiac disease
• LVEF ¡Ý 40%
• No symptomatic pulmonary disease
• FEV_1, FVC, and DLCO ¡Ý 50% of predicated (without bronchodilator)
• No history of HIV positivity or AIDS
• No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product
• No history of Wegener's granulomatosis or vasculitis

PRIOR CONCURRENT THERAPY:

• Recovered from prior surgery and/or radiotherapy
• No prior allogeneic or syngeneic stem cell transplantation
• No prior solid organ transplantation
• No prior vaccine therapy for AML
• More than 28 days since prior chronic use (> 2 weeks) of corticosteroids > 10 mg/day (prednisone [or equivalent])
• Concurrent topical or inhaled corticosteroids allowed
• More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus
No concurrent radiotherapy

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