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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020670
  Purpose

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
Leukemia
Biological: autologous tumor cell vaccine
Phase I

Study Type: Interventional
Study Design: 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:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020670

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: W. Nicholas Haining, BM, BCh Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068701, DFCI-00053, NCI-H01-0074
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00020670     History of Changes
Health Authority: United States: Federal Government

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:
Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 25, 2009