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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 11, 2001
Last updated: February 6, 2009
Last verified: August 2003

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.

Condition Intervention Phase
Biological: autologous tumor cell vaccine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • See Disease Characteristics

Performance status:

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

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Treatment portion of the study:

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


  • Treatment portion of the study:

    • Creatinine less than 2 times normal


  • No clinically significant cardiovascular disease


  • No clinically significant pulmonary disease


  • 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


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


  • 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


  • Treatment portion of the study:

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


  • Not specified


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00020670

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: W. Nicholas Haining, BM, BCh Dana-Farber Cancer Institute
  More Information Identifier: NCT00020670     History of Changes
Other Study ID Numbers: CDR0000068701
Study First Received: July 11, 2001
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
B-cell adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 23, 2017