Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020670
First received: July 11, 2001
Last updated: February 6, 2009
Last verified: August 2003
  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 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:

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
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 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

ClinicalTrials.gov Identifier: NCT00020670     History of Changes
Other Study ID Numbers: CDR0000068701, DFCI-00053, NCI-H01-0074
Study First Received: July 11, 2001
Last Updated: February 6, 2009
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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014