OBJECTIVES:

• Determine the feasibility of generating a vaccine comprising CD40-activated autologous leukemic cells for patients with B-cell acute lymphoblastic leukemia (ALL).
• Determine the feasibility of this regimen in patients with B-cell ALL.
• Determine the toxicity of this regimen in these patients.
• Assess the ALL-specific immunity in patients treated with this regimen.
• Assess the generation of immunity to control antigens in patients treated with this regimen.
• Determine, in a preliminary manner, the effect of this regimen on tumor response in these patients.

OUTLINE: This is a multicenter study.

Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin, and then irradiated.

Beginning a minimum of 1 week after tumor cell collection, patients receive vaccination with autologous CD40-activated ALL cells subcutaneously and intradermally on weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. After completion of 4 vaccinations, patients who have more aliquots of vaccine available from the initial tumor cell collection may receive additional vaccinations every 2 weeks in the absence of disease progression or unacceptable toxicity. Vaccination may be postponed for a maximum of 1 year after tumor cell collection in patients who receive chemotherapy and/or allogeneic stem cell transplantation.

Patients are followed at approximately 2 months after last vaccination.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell acute lymphoblastic leukemia

  • Disease involving at least 30% of bone marrow or circulating blasts

  • Must meet 1 of the following conditions:

    • In first relapse with at least 1 of the following high-risk features:

      • Age under 1 year at diagnosis
      • Age over 18 years at diagnosis
      • t(9;22)
      • Occurrence of first relapse less than 18 months after diagnosis
    • In second relapse or beyond
    • Refractory disease

• Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine

  • Less than 1 year since tumor cell collection

  • Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine

    • Patients need not be in complete remission to receive study vaccine

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

Performance status:

• Lansky 60-100% OR
• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Treatment portion of the study:

  • Bilirubin less than 2 times normal
  • AST less than 3 times normal
  • ALT less than 6 times normal

Renal:

• Treatment portion of the study:

  • Creatinine less than 2 times normal

Cardiovascular:

• No clinically significant cardiovascular disease

Pulmonary:

• No clinically significant pulmonary disease

Other:

• No clinically significant autoimmune disease
• No documented infection that is active and/or not responding to therapy
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• Tumor cell collection portion of the study:

  • At least 3 days since prior immunotherapy

• Treatment portion of the study:

  • Prior allogeneic hematopoietic stem cell transplantation allowed
  • No immunotherapy for at least 3 weeks before and during study vaccination
  • No concurrent hematopoietic growth factors

Chemotherapy:

• Tumor cell collection portion of the study:

  • At least 3 days since prior chemotherapy

• Treatment portion of the study:

  • No chemotherapy for at least 3 weeks before and during study vaccination

Endocrine therapy:

• Treatment portion of the study:

  • No concurrent oral or IV corticosteroids as antiemetics

Radiotherapy:

• Treatment portion of the study:

  • No radiotherapy for at least 3 weeks before and during study vaccination

Surgery:

• Not specified

Other:

• Tumor cell collection portion of the study:

  • At least 3 days since prior immunosuppressive therapy

• Treatment portion of the study:

  • No immunosuppressive therapy for at least 3 weeks before and during study vaccination
  • No concurrent local anesthetic cream (e.g., EMLA)

• Both portions of the study:

  • No concurrent therapy on another research protocol