Overview

This trial is active, not recruiting.

Condition leukemia
Treatment autologous tumor cell vaccine
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date January 2001
Trial identifier NCT00020670, CDR0000068701, DFCI-00053, NCI-H01-0074

Summary

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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).