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Status:

UNKNOWN

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

Lead Sponsor:

The Vaccine Company

Conditions:

Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells ...

Detailed Description

OBJECTIVES: Primary * Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CS...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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 ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia
  • In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 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% (≤ 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 ≤ 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 ≥ 40%
  • No symptomatic pulmonary disease
  • FEV\_1, FVC, and DLCO ≥ 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    244 Patients enrolled

    Trial Details

    Trial ID

    NCT00454168

    Start Date

    May 1 2005

    Last Update

    January 6 2014

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    3

    Vaccine Company

    South San Francisco, California, United States, 94080

    4

    Rush Cancer Institute at Rush University Medical Center

    Chicago, Illinois, United States, 60612