Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia

Summary: RATIONALE: Vaccines made from cancer cells may make the body build an immune response to kill cancer cells.
  PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have acute lymphoblastic leukemia.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant