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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia Clinical research trials and Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia. Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia clinical trial. Participants oftentimes recieve the most expert healthcare available for their Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia  Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
For Condition: recurrent childhood acute lymphoblastic leukemia,B-cell childhood acute lymphoblastic leukemia,B-cell adult acute lymphoblastic leukemia,recurrent adult acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.Haining, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: CDR0000068701; NCI-H01-0074,DFCI-00053
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020670
Other Recurrent Adult Acute Lymphoblastic Leukemia Studies:
1. Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
2. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
3. Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
4. Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia
5. Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Related Studies:
Other recurrent adult acute lymphoblastic leukemia Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
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