Hairy Cell Leukemia |
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Clinical Trial: Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
This study is no longer recruiting patients.
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
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:
- 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:
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
Location Information
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States
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
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
- Acute Lymphoblastic Leukemia, Adult (National Cancer Institute)
- Hairy Cell Leukemia (Cleveland Clinic)

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