A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
N/A
N/A
Both
Leukemia
Trial Information
A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
W. Nicholas Haining, BM, BCh
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068701
NCT ID:
NCT00020670
Start Date:
January 2001
Completion Date:
Related Keywords:
- Leukemia
- recurrent childhood acute lymphoblastic leukemia
- recurrent adult acute lymphoblastic leukemia
- B-cell childhood acute lymphoblastic leukemia
- B-cell adult acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
