Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
This trial is active, not recruiting.
|Treatment||autologous tumor cell vaccine|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2001|
|Trial identifier||NCT00020670, CDR0000068701, DFCI-00053, NCI-H01-0074|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
Male or female participants of any age.
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
|Official title||A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells|
|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.|
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