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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia - Article


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Hairy Cell Leukemia

 




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

This study is no longer recruiting patients.

Sponsors and Collaborators: Dana-Farber/Harvard Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent childhood acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
B-cell adult acute lymphoblastic leukemia
 Drug: autologous tumor cell vaccine
 Procedure: biological response modifier therapy
 Procedure: tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of CD40-Activated Autologous Tumor Cell Vaccine in Patients With B-Cell Acute Lymphoblastic Leukemia

Further Study Details: 

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

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:

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:


Location Information


Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

W. Nicholas Haining, BM, BCh,  Study Chair,  Dana-Farber/Harvard Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068701; DFCI-00053; NCI-H01-0074
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020670
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 30, 2009



Page Updated: October 15, 2009
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